[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,139,0,25,[9,54,77,110,139,163,197,222,253,281,304,331,362,383,403,430,458,482,513,531,558,582,604,634,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100053768","atrial-cardiomyopathy-in-patients-with-cardiovascular-kidney-metabolic-syndrome-non-invasive-characterization-100053768",false,"NCT07697469","Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization","Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)","ATRIO-CKM","Inclusion Criteria:\n\n* Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements\n\nExclusion Criteria:\n\n* Missing key data for ACM or CKM classification Hemodynamically significant valvular heart disease (greater than moderate severity) Mechanical or biological valve prostheses Temporary or permanent cardiac pacing Psychiatric pathology Thyroid pathology (active or untreated) Known cardiomyopathies (hypertrophic, dilated, restrictive, or infiltrative) Refusal to participate or inability to comply with protocol requirements","ALL","18 Years",{"count":21,"type":22},200,"ESTIMATED","OBSERVATIONAL","Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group.\n\nCKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate.\n\nThis prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI.\n\nAdults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking.\n\nPrimary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel.\n\nStatistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.",[26,27,28,29,30],"Cardiovascular-Kidney-Metabolic Syndrome","Atrial Cardiomyopathy","Atrial Fibrillation","Chronic Kidney Disease","Metabolic Syndrome",[32,33,34,35,36,37,38,39,40,28,29],"atrial cardiomyopathy","CKM syndrome","on-invasive evaluation","atrial remodeling","Bayés interatrial block","speckle tracking","Fetuin-A","MR-proANP","FGF23","NOT_YET_RECRUITING","2026-07-05",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":22},"2026-07-10",{"date":49,"type":22},"2028-04",{"name":51,"class":52},"Grigore T. Popa University of Medicine and Pharmacy","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":23,"phases":4,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":53},"100629965","a-prospecitve-multicenter-observational-registry-study-100629965","NCT07481526","A Prospecitve Multicenter, Observational Registry Study","A Multicenter Real-World Registry of Characteristics, Treatment Strategies, and Clinical Outcomes in Chinese Adults With Chronic Kidney Disease","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years.\n* Willing and able to provide written informed consent to participate in the study.\n* Confirmed CKD diagnosis at enrolment, defined by at least one of the following:\n\n  * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² for ≥3 months, OR\n  * Evidence of kidney damage (e.g., UACR ≥30 mg\u002Fg or UPCR ≥150 mg\u002Fg, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months\n\nExclusion Criteria:\n\n* Having a life-threatening comorbidity with life expectancy \\\u003C 2 years.\n* Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.\n* Pregnant or breastfeeding women.\n* Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.\n* Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.",{"count":62,"type":22},3000,"96 Weeks","This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.",[29],"RECRUITING","2026-07-01",{"date":69,"type":45},"2026-07-02",{"date":71,"type":45},"2026-02-27",{"date":73,"type":22},"2028-12-30",{"name":75,"class":76},"AstraZeneca","INDUSTRY",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100594851","phase-1-a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4248-in-healthy-participants-and-participants-with-chronic-kidney-disease-and-type-2-diabetes-and-to-assess-home-measurements-of-creatinine-in-a-non-interventional-cohort-100594851","NCT07024823","A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort","A Phase I Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 Following Single and Multiple Ascending Dose Administration in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Prospective, Non-interventional Cohort Study","Key Inclusion Criteria:\n\n\\- Healthy participants with suitable veins for cannulation or repeated venipuncture.\n\nParts A and B:\n\n* Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg\u002Fm2), inclusive.\n* For Chinese participants (Part A2): participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.\n* For Japanese participants (Part B2): participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.\n\nPart C:\n\n* Have a BMI between 20 and 40 kg\u002Fm2, inclusive.\n* Have a diagnosis of diabetic kidney disease (DKD).\n* Hemoglobin A1C (HbA1c) of ≤ 10.5%.\n* Participants are required to be on a stable dose of angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.\n\nPart D:\n\n* Have a BMI between 20 and 35 kg\u002Fm2, inclusive.\n* Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values.\n* HbA1c of ≤ 10.5%.\n* Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for ≥ 6 weeks before Screening.\n* Participants must be able and motivated to use the home creatinine device and smartphone independently by successfully performing the test without assistance from site staff.\n* Participants must be able to read and understand English sufficient to participate in site visits and home testing.\n\nKey Exclusion Criteria:\n\n* History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.\n* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV).\n\nParts A and B:\n\n* History or presence of gastrointestinal, hepatic, or renal disease.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.\n* Participants who have previously received AZD4248.\n\nPart C:\n\n* History or presence of gastrointestinal, hepatic, or renal disease.\n* Any clinically important illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4248.\n* Use of drugs that are strong or moderate CYP3A4 inhibitors\u002Finducers or P-gp inhibitors from within 3 weeks before Screening until the end of the last sample collection.\n* Participants who have previously received AZD4248.\n* Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.\n* Expected change of dosing regimen during the study.\n* History of clinically significant heart or vascular disease.\n* New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening.\n* Ventricular arrhythmias requiring treatment.\n* Amputation due to peripheral artery disease.\n* Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months.\n\nPart D:\n\n* Participants on serum creatinine-altering drugs should be on long-term treatment at a stable dose prior to study entry.\n* Expected change of dosing regimen during the study.",true,"75 Years",{"count":87,"type":22},124,"INTERVENTIONAL",[90],"PHASE1","This study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of AZD4248 administered as an oral solution and intravenous (IV) infusion. Additionally, the study investigates the non-interventional feasibility of home measurement of serum creatinine in participants with diabetic kidney disease (DKD).",[29],[94,95,96,97,98,99,100,101],"Type 2 Diabetes","Diabetic Kidney Disease","Multiple Ascending Dose","Single Ascending Dose","Creatinine","Food Effect","Pharmacokinetics","Safety","2026-06-30",{"date":67,"type":45},{"date":105,"type":45},"2025-06-09",{"date":107,"type":22},"2026-12-25",{"name":75,"class":76},5,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":84,"sex":18,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":53},"100469897","a-natural-history-study-of-metabolic-sizing-in-health-and-disease-100469897","NCT05398783","A Natural History Study of Metabolic Sizing in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:\n\nCohort 1 - Healthy Volunteers\n\n* Male or female, aged \\>=2 years\n* In good general health as evidenced by medical history\n\nCohort 2 - Patients\n\n* Male or female, aged \\>=2 years\n* Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants over 200 kg due to the weight limit of the equipment.\n* Presence of any implanted device that would interfere with measurements.\n* Any moderate to severe limitations in mobility that would impede participation\n* Hemoglobin less than 10 g\u002FdL (in participants who would have blood drawn for research purposes).\n* Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n* Participants unwilling or unable to give informed consent.\n* Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.","2 Years","99 Years",{"count":119,"type":22},2000,"Background:\n\nScientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.\n\nObjective:\n\nThis natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.\n\nEligibility:\n\nHealthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.\n\nDesign:\n\nParticipants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.\n\nParticipants will undergo many tests:\n\nThey will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.\n\nThey will lie on a padded table for about 15 minutes while their body is scanned.\n\nThey will stand on a platform while a 3D scanner measures their body.\n\nThey will have a test to measure how fast an electric signal moves through their body.\n\nThey will grip an instrument to measure the strength of their hands.\n\nThey will drink salty water and provide blood and urine samples.\n\nParticipants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.",[122,123,29,124,125],"Metabolic Disorders","Cancer","Diabetes","Normal Physiology",[127,128,129,130],"Body Composition","Metabolism","Body Surface Area","Natural History",{"date":67,"type":45},{"date":133,"type":45},"2022-10-25",{"date":135,"type":22},"2031-07-01",{"name":137,"class":138},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":53},"100635575","an-observational-study-called-finexplorer-to-learn-more-about-how-well-finerenone-works-in-adults-in-spain-with-chronic-kidney-disease-ckd-linked-to-type-2-diabetes-by-looking-at-changes-in-a-ckd-risk-score-100635575","NCT07554469","An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score","An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain","FINEXPLORER","Inclusion Criteria:\n\n* Patients who sign the written informed consent to participate in the study.\n* Men or women aged ≥18 years.\n* Patients with CKD associated with type 2 diabetes and albuminuria (UACR \\>30 mg\u002Fg).\n* Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.\n\nExclusion Criteria:\n\n* eGFR \\\u003C 25 mL\u002Fmin\u002F1.73 m².\n* Severe hepatic impairment.\n* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.\n* Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.\n* Uncontrolled arterial hypertension (mean sitting systolic blood pressure \\[SBP\\] ≥160 mmHg or diastolic blood pressure \\[DBP\\] ≥100 mmHg at inclusion).\n* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or a potassium-sparing diuretic that has not been discontinued at least 4 weeks prior to inclusion.",{"count":148,"type":22},500,"This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.\n\nChronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model.\n\nThe study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine.\n\nFinerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes.\n\nThe main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on:\n\n* Clinical characteristics of participants, including their medical history related to CKD and T2D.\n* Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN).\n* Participants' glucose, hemoglobin and potassium levels.\n\nThe study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.\n\nData will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).",[29,151],"Type 2 Diabetes Mellitus",[153,29,151],"Finerenone","2026-06-26",{"date":156,"type":45},"2026-06-29",{"date":158,"type":45},"2026-05-26",{"date":160,"type":22},"2029-04-30",{"name":162,"class":76},"Bayer",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":84,"sex":18,"minAge":171,"maxAge":85,"enrollmentInfo":172,"targetDuration":4,"studyType":88,"phases":174,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":53},"100639438","uppsala-self-screening-of-cardiovascular-health-100639438","NCT07614659","Uppsala Self-Screening of Cardiovascular Health","Uppsala Self-Screening of Cardiovascular Health: A Randomized Controlled Trial of Home-Based Multimodal Cardiovascular Screening Versus Usual Care in Middle-Aged and Older Adults","U-SCREEN","Inclusion Criteria:\n\n* Resident in Region Uppsala, Sweden\n* Turning 50, 55, 60, 65, 70 or 75 years during recruitment period\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Protected identity","50 Years",{"count":173,"type":22},45000,[175],"NA","U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.",[178,179,180,181,28,29],"Cardiovascular Diseases","Hypertension","Dyslipidemias","Diabetes Mellitus",[183,184,185,186,187,188,189],"Population screening","Cardiovascular prevention","Home blood pressure monitoring","Dried blood spot","Digital health","Pragmatic trial","Register-based randomized controlled trial",{"date":102,"type":45},{"date":192,"type":45},"2025-02-01",{"date":194,"type":22},"2037-12",{"name":196,"class":52},"Johan Sundström",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":205,"maxAge":19,"enrollmentInfo":206,"targetDuration":4,"studyType":88,"phases":208,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100474390","phase-3-a-study-to-learn-more-about-how-safe-the-study-treatment-finerenone-is-in-long-term-use-when-taken-with-an-ace-inhibitor-or-angiotensin-receptor-blocker-over-18-months-of-use-in-children-and-young-adults-from-1-to-18-years-of-age-with-chronic-kidney-disease-and-proteinuria-100474390","NCT05457283","A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","FIONA OLE","Inclusion Criteria:\n\n* Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent\u002Fassent.\n* Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.\n* Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as\n\n  * CKD stages 1-3 (estimated glomerular filtration rate \\[eGFR\\] ≥30 mL\u002Fmin\u002F1.73m\\^2) for children ≥1 year to \\\u003C19 years of age at FIONA EoT and at Visit 1\n* Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.\n* K+ ≤5.0 mmol\u002FL for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol\u002FL for children \\\u003C2 years of age at both FIONA EoT and Visit 1\n* Participants who have reached legal age of consent: Capable of giving signed informed consent.\n* Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.\n\nExclusion Criteria:\n\n* Planned urological surgery expected to influence renal function\n* Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame\n* Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.\n* Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \\\u003C18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \\\u003C90 mmHg in participants ≥18 years at Visit 1.\n* Known hypersensitivity to the study treatment (active substance or excipients)\n* Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.\n* Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids\n* Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril\u002Fvalsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)\n* Concomitant therapy with both ACEI and ARBs together\n* Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers\n* Previous assignment to treatment during this study\n* Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).\n* Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.\n* Pregnant or breastfeeding or intention to become pregnant during the study","1 Year",{"count":207,"type":22},100,[209],"PHASE3","Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.\n\nThe kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and\u002For proteinuria. These include \"angiotensin-converting enzyme inhibitors\" (ACEI) and \"angiotensin receptor blockers\" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.\n\nThe study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.\n\nSo, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.\n\nThe main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.\n\nTo see how safe the treatment is, the study team will collect information on medical problems which are also known as \"treatment emergent adverse events\" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.\n\nThe secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care.\n\nTo see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.\n\nThe study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.\n\nThe participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.\n\nIn the visit, the study team will:\n\n* have their blood pressure, heart rate, temperature, height and weight measured\n* have blood and urine samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer\n* answer questions about how they are feeling, or have their parents or guardian's answer\n* answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health about 30 days after the participants take their last treatment.",[29,212,213],"Proteinuria","Children","2026-06-25",{"date":154,"type":45},{"date":217,"type":45},"2022-11-08",{"date":219,"type":22},"2028-12-28",{"name":162,"class":76},179,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":231,"conditions":232,"keywords":241,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":53},"100638972","periodontal-disease-in-rare-renal-disorders-perio-ra-re-100638972","NCT07575347","Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)","Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease","PERIO-RA-RE","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* At least 10 natural teeth present\n* Belonging to one of the predefined study groups:\n\n  1. Alport syndrome (genetically or clinically confirmed)\n  2. Fabry disease (enzymatically or genetically confirmed)\n  3. Tuberous sclerosis complex (according to established clinical or genetic criteria)\n  4. Systemic lupus erythematosus defined according to the 2019 EULAR\u002FACR or SLICC 2012 classification criteria, with renal involvement defined by at least one of the following: \\[1\\] Biopsy-proven lupus nephritis, \\[2\\] Persistent proteinuria (\\>0.5 g\u002Fday or equivalent), \\[3\\] Active urinary sediment (hematuria and\u002For cellular casts) consistent with lupus nephritis\n  5. Chronic kidney disease (CKD) of non-rare etiology: defined according to KDIGO criteria (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m² and\u002For markers of kidney damage)\n  6. Individuals without CKD, recruited from clinical or dental care settings as non-CKD controls\n\nExclusion Criteria:\n\n* Periodontal treatment within the last 6 months\n* Antibiotic therapy within the last 4 weeks\n* Pregnancy\n* Conditions precluding periodontal examination\n* Inability to comply with study procedures",{"count":207,"type":22},"This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls.\n\nThis is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data.\n\nThe primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes.\n\nExploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.",[233,234,235,29,236,237,238,239,240],"Periodontal Disease","Periodontitis","CKD","Alport Syndrome","Fabry Disease","Lupus or SLE","Tuberous Sclerosis Complex (TSC)","Systemic Lupus Erythematosus (SLE)",[233,234,235,242,243,244,239,29],"Rare Kidney Diseases","Alport syndrome","Systemic Lupus Erythematosus","2026-06-24",{"date":154,"type":45},{"date":248,"type":45},"2026-05-04",{"date":250,"type":22},"2027-12-31",{"name":252,"class":52},"Stefan Lujinschi",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":88,"phases":262,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":53},"100546551","phase-4-obesity-management-for-kidney-transplantation-ok-transplant-2-100546551","NCT06396416","Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2","Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* BMI; 35 kg\u002Fm\\^2\n* 10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis\n\nExclusion Criteria:\n\n* Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity)\n* Type 1 diabetes\n* No access to semaglutide via drug coverage\n* Pregnant, breastfeeding or planning to become pregnant\n* Currently in a GLP-1RA or GLP-1RA\u002FGIP study or planning to be in one",{"count":261,"type":22},60,[263],"PHASE4","OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.\n\nWe will randomize participants with obesity, high-risk CKD\u002Fdialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.",[266,29],"Obesity",[268,269,270,271,272,273],"Weight Management","Transplant","GLP-1RA","Pilot Study","Registries","Pragmatic",{"date":156,"type":45},{"date":276,"type":45},"2024-09-26",{"date":278,"type":22},"2026-12",{"name":280,"class":52},"Western University, Canada",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":18,"minAge":116,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":88,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100601242","phase-3-a-study-to-find-out-how-empagliflozin-is-tolerated-and-if-it-helps-children-and-adolescents-with-chronic-kidney-disease-empa-kidney-kids-100601242","NCT07107945","A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)","A Randomised, Double-blind, Placebo-controlled Trial With an Open-label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients With Chronic Kidney Disease (EMPA-KIDNEY® Kids)","Inclusion Criteria:\n\n* Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity).\n* Age 2 to 17 years at screening Visit 1.\n* Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to \\\u003C90 mL\u002Fmin\u002F1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg\u002Fg\n* Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial.\n* Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Confirmed type 1 or type 2 diabetes mellitus.\n* History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation.\n* Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial.\n* Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion).\n* Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children \\\u003C4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1.\n* Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.\n* Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1.\n* Severe, uncontrolled hypertension (based on investigator's judgement).\n* Further exclusion criteria apply.","17 Years",{"count":290,"type":22},120,[209],"This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year.\n\nParticipants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.",[29],"2026-06-22",{"date":296,"type":45},"2026-06-23",{"date":298,"type":45},"2025-12-09",{"date":300,"type":22},"2029-06-25",{"name":302,"class":76},"Boehringer Ingelheim",102,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":171,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":88,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure",{"count":312,"type":22},7140,[209],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[316,29],"Atherosclerosis Cardiovascular Disease",[318,319,320,321],"Heart Disease","Kidney Disease","Outcomes","Stroke","2026-06-19",{"date":296,"type":45},{"date":325,"type":45},"2025-12-01",{"date":327,"type":22},"2031-08",{"name":329,"class":76},"Eli Lilly and Company",568,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":116,"maxAge":288,"enrollmentInfo":338,"targetDuration":4,"studyType":88,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100513799","phase-3-a-study-of-roxadustat-to-treat-anemia-in-children-and-teenagers-with-chronic-kidney-disease-100513799","NCT05970172","A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease","A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n* Participant has a diagnosis of anemia in CKD Kidney Disease Outcomes Quality Initiative stages 3 or 4 or 5. This can include participants not on dialysis or dialysis dependent (DD) participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants).\n* Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of \\\u003C 60 mL\u002Fmin per 1.73 m\\^2.\n* ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g\u002FdL; ESA-naïve participants can have a Hb level ≤ 11 g\u002FdL.\n* Participant has a ferritin level \\> 100 ng\u002FmL or a transferrin saturation (TSAT) value \\> 20%.\n* Participant has an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) and total bilirubin (TBL) ≤ 1.5 x ULN at enrollment visit.\n* Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as:\n\n  * ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening.\n  * ESA-naïve: Participant has no prior ESA exposure OR participant's total prior ESA exposure ≤ 3 weeks within the preceding 4 weeks from screening OR participant was previously treated with and discontinued an ESA ≥ 8 weeks prior to screening.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 4 weeks after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening and throughout the study and for 4 weeks post-last roxadustat dose.\n* Female participant must not donate ova starting at first administration of roxadustat and throughout the study period and for 4 weeks post-last roxadustat dose.\n* Male participants with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 4 weeks post-last roxadustat dose.\n* Male participants must not donate sperm during the treatment period and for 4 weeks post-last roxadustat dose.\n* Male participants with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 4 weeks post-last roxadustat dose.\n* Participant and\u002For participant's parent or legal guardian agrees for the participant not to participate in another interventional study while participating in the present study.\n\nExclusion Criteria:\n\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has any medical condition, including active, systemic or clinically significant infection which may pose a safety risk to a participant in this study, which may confound the safety or activity assessment or may interfere with study participation making the participant unsuitable for study.\n* Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), or any components of the formulation used.\n* Participant has uncontrolled hypertension (defined as ≥ 95th percentile + 12 mm Hg or ≥ 140\u002F90 mm Hg \\[whichever is lower\\] for participants \\\u003C 13 years of age and ≥ 140\u002F90 mm Hg for participants ≥ 13 years of age measured 3 times at the same visit) in the 2 weeks prior to screening.\n* Participant has a known hematologic disease other than anemia secondary to renal disease,(e.g., history of sickle cell disease, sickle cell anemia, hemoglobin sickle cell disease, or hemoglobin sickle cell beta thalassemia).\n* Participant has untreated hypothyroidism.\n* Participant has severe hyperparathyroidism defined as serum parathyroid hormone (PTH) levels above 1000 pg\u002FmL intact PTH within 4 weeks of screening.\n* Participant has a functioning kidney allograft.\n* Participant has a folate or B12 or carnitine deficiency. Acceptable if treated to normal values within 4 weeks of screening.\n* Participant has a known active malignancy or malignancy within 18 months before the screening visit. Radiation or chemotherapy must be completed at least 12 months before the screening visit.\n* Participant has a scheduled living donor organ transplantation date within 12 weeks of screening. If participant becomes eligible for a kidney transplant during study conduct, the participant should be discontinued.\n* Participant has a whole blood or packed red blood cells (pRBC) transfusion during the 8 weeks prior to screening.\n* Participant has any current condition leading to active significant blood loss in the past 4 weeks.\n* Participant has a diagnosis of hemolytic uremic syndrome within 12 weeks prior to screening.\n\n  * Participant who has a previous diagnosis of atypical hemolytic syndrome must be relapse-free (stable hemoglobin (Hb), normal platelet count, normal serum lactate dehydrogenase, and normal haptoglobin level) for more than 12 weeks prior to screening.\n* Participant has a history of chronic liver disease, including comorbidity with autosomal recessive polycystic kidney disease, cystinosis, and primary hyperoxaluria.\n* Participant had an episode of peritonitis within 30 days of screening.\n* Participant has active inflammation such as glomerulonephritis flare (i.e., lupus nephritis, immunoglobulin A (IgA) nephritis, rapidly progressive glomerulonephritis, membranoproliferative glomerulonephritis, antineutrophil cytoplasmic antibodies vasculitis) requiring pulse corticosteroid treatment or induction treatment with an immunosuppressive agent (i.e., cyclophosphamide, rituximab, or another monoclonal antibody) within 6 weeks of screening visit. Receipt of monoclonal antibody or biologic for maintenance treatment of underlying condition is acceptable.\n* Participant has a known history of human immunodeficiency virus infection.\n* Participant has rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or is allergic to peanut or soya.",{"count":207,"type":22},[209],"Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells. Current treatment for anemia is to have injections of medicines called erythropoietin stimulating agents (also known as ESAs) to help the bone marrow make more red blood cells. These are often given together with iron. This treatment is also available to children and teenagers with CKD. However, there are some safety concerns with ESAs. Also, as roxadustat is taken orally, this may be another option for treating anemia in children and teenagers with CKD. In this study, children and teenagers with CKD and anemia will take roxadustat for up to 52 weeks to treat their anemia.\n\nThe main aim of the study is to learn how roxadustat affects anemia in children and teenagers with CKD.\n\nThis is an open-label study which means the children and teenagers in the study and the clinic staff know they will be taking roxadustat. In this study, the children and teenagers with CKD who need treatment for anemia can take part. Those currently being treated with an ESA will be switched to roxadustat. Those who have not been treated with an ESA can start on roxadustat straight away. All children and teenagers in the study will take roxadustat 3 times a week for up to 52 weeks (1 year). They will start on a fixed dose of roxadustat for 4 weeks. Blood samples will be taken regularly to check hemoglobin levels. The roxadustat dose may be changed if the blood levels of hemoglobin are too high, too low, or change too quickly. After 4 weeks the dose may be changed, if needed, to keep blood levels of hemoglobin in the blood to just below the normal range.\n\nFirstly, teenagers will take roxadustat. 10 teenagers will take their fixed dose of roxadustat for 4 weeks. They will give blood samples to help the researchers work out the most suitable dose for the rest of the teenagers in the study. When the rest of the teenagers start taking roxadustat at the most suitable dose for teenagers, 10 children will take roxadustat for 4 weeks. These 10 children will give blood samples to help the researchers work out the most suitable dose for the rest of the children in the study. Then, the rest of the children will take roxadustat at the most suitable dose for children.\n\nThere will be many clinic visits during the study. Overnight hospital stays are not expected. There will be 1 visit every 2 weeks for the first 4 weeks of taking roxadustat, then every 4 weeks until the end of treatment. Finally there is 1 visit 4 weeks after treatment has finished.\n\nDuring most visits, the children and teenagers will have their vital signs checked (blood pressure, body temperature and heart rate). Fluid status (how much water is in the body) will also be checked for those who need dialysis. The children and teenagers will also have blood tests and the study doctors will check for any medical problems. The children and teenagers will have a medical examination before their first dose of roxadustat and again at about 24-week (6-month) and 52-week (13-month) visits. They will have an electrocardiogram (ECG) before their first dose of roxadustat and again at the 12-week, 24-week, 36-week, and 52-week visit. They will also have urine tests at the 4-week, 24-week and 52-week visits. At the 52-week visit, the children and teenagers will also have blood tests for hemoglobin and iron levels. The study doctors will also check for any medical problems.",[29,342],"Renal Anemia",[344,345,346,342,347,29,348,349,350,351,101,100,352],"Roxadustat","ASP1517","Pediatric","Chronic renal failure","Renal Insufficiency, Chronic","Anemia","Open-label","Uncontrolled","Pharmacodynamics","2026-06-18",{"date":294,"type":45},{"date":356,"type":45},"2024-01-16",{"date":358,"type":22},"2027-10-30",{"name":360,"class":76},"Astellas Pharma Global Development, Inc.",47,{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":370,"maxAge":288,"enrollmentInfo":371,"targetDuration":4,"studyType":88,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100454322","phase-3-a-study-to-learn-more-about-how-well-the-study-treatment-finerenone-works-how-safe-it-is-how-it-moves-into-through-and-out-of-the-body-and-the-effects-it-has-on-the-body-when-taken-with-an-ace-inhibitor-or-angiotensin-receptor-blocker-in-children-with-chronic-kidney-disease-and-proteinuria-100454322","NCT05196035","A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria","A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK\u002FPD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to \u003C18 Years of Age, With Chronic Kidney Disease and Proteinuria","FIONA","Inclusion Criteria:\n\n* Participants must be 6 months to \\\u003C18 years old at the time when the informed consent\u002Fassent is signed\n* Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as\n\n  * CKD stages 1-3 (eGFR ≥30 mL\u002Fmin\u002F1.73m\\^2) for children ≥1 year to \\\u003C18 years of age or\n  * a serum creatinine ≤ 0.40 mg\u002FdL for infants 6 months to \\\u003C 1 year of age and\n  * severely increased proteinuria as defined by\n\n    * Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g\u002Fg in participants ≥ 2 years with CKD stage 2 and 3 or\n    * UPCR ≥ 1.0 g\u002Fg for patients \\\u003C 2 years of age or ≥ 2 years of age and with CKD stage 1\n* Participants must have stable kidney function between screening and D0 defined as:\n\n  * For participants with a creatinine of \\> 0.8 mg\u002FdL at screening: no increase or decrease in eGFR by ≥ 20% at D0\n  * For participants with a creatinine of ≤ 0.8 mg\u002FdL at screening: no increase or decrease in creatinine ≥ 0.15 mg\u002FdL at D0.\n* Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening\n* K+ ≤5.0 mmol\u002FL for children ≥2 years of age at both screening and D0, and ≤5.3 mmol\u002FL for children \\\u003C2 years of age at both screening and D0\n\nExclusion Criteria:\n\n* Planned urological surgery expected to influence renal function\n* Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening\n* Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening\n* Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame\n* Renal allograft in place\n* Bilateral renal artery stenosis\n* Acute kidney injury requiring dialysis within 6 months prior to screening\n* Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization\n* Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to \\\u003C1 year of age at screening or randomization\n* Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is \\\u003C 80 mmHg they must be excluded if their SBP is \\\u003C80 mmHg)\n* Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within \\\u003C6 months prior to screening","6 Months",{"count":372,"type":22},219,[209],"Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.\n\nThe kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and\u002For proteinuria. These include \"angiotensin-converting enzyme inhibitors\" (ACEI) and \"angiotensin receptor blockers\" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.\n\nThe study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.\n\nSo, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.\n\nThe main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.\n\nTo see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests.\n\nThis study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:\n\n* either finerenone or the placebo, in addition to\n* either ACEI or ARB, whichever they take as part of their normal treatment\n\nTwo visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will:\n\n* have their blood pressure, heart rate, temperature, height and weight measured\n* have blood and urine samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)\n* answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer\n* answer questions about how they are feeling, or have their parents or guardians answer\n* answer question about how they like the study medication, or have their parents or guardians answer\n\nThe doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health about 30 days after the participants take their last treatment.",[29,212],{"date":294,"type":45},{"date":378,"type":45},"2022-03-28",{"date":380,"type":22},"2027-06-30",{"name":162,"class":76},164,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},"100537467","an-observational-study-called-finerod-to-learn-more-about-the-use-of-the-treatment-finerenone-including-how-safe-it-is-and-how-well-it-works-under-real-world-conditions-100537467","NCT06278207","An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions","Finerenone Research of Outcomes and Drug Utilization","FINEROD","Inclusion Criteria:\n\n* A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used\n* No recorded prescription for finerenone in the 12 months prior to the index date\n* Age of 18 years or older as of the index date\n* Evidence of T2D at any point before (and including) the index date.\n* CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:\n\n  * A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified\n  * two UACR tests results ≥ 30 mg\u002Fg separated by at least 90 days and by not more than 540 days\n  * two different eGFR test results ≥ 15 mL\u002Fmin\u002F1.73 m2 AND \\\u003C 60 mL\u002Fmin\u002F1.73 m2 separated by at least 90 days and by not more than 540 days\n\nExclusion Criteria:\n\n\\- Kidney failure defined as follows:\n\n* Two different eGFR test results \\\u003C 15 mL\u002Fmin\u002F1.73 m2 separated by at least 90 days and by not more than 540 days;\n* Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);\n* A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant",{"count":392,"type":22},50000,"This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.\n\nThe researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.\n\nThe data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.",[29,151],"2026-06-17",{"date":353,"type":45},{"date":398,"type":45},"2024-05-15",{"date":400,"type":22},"2026-09-30",{"name":162,"class":76},4,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":410,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":88,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":53},"100641352","effectiveness-of-subgingival-instrumentation-on-delaying-end-stage-renal-disease-among-chronic-kidney-disease-patients-100641352","NCT07635797","Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients","Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients: A Non-Randomized Clinical Study","Inclusion Criteria:\n\n* Patients aged 40-70 years.\n* Type 2 diabetes mellitus with chronic kidney disease and currently on oral hypoglycaemic agents.\n* Diagnosed with Stage IV or V (eGFR between 15-20 mL\u002Fmin\u002F1.73m²).\n* Not undergoing dialysis.\n* Presence of ≥20 natural teeth.\n* Diagnosed with moderate (Stage II) (as per 2017 World Workshop classification) (Interdental CAL at site of greatest loss \\>2mm but \\\u003C5 mm in ≥ 2 non-adjacent teeth).\n* Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients already undergoing haemodialysis or renal transplantation.\n* Patients on insulin therapy or taking SGLT2 inhibitors and GLP-1 receptor agonists.\n* HbA1c level \\>8 %.\n* Any Periodontal therapy within past 6 months.\n* Immunocompromised patients.\n* Any history of tobacco use.\n* Pregnant or lactating women.","40 Years","70 Years",{"count":413,"type":22},40,[175],"Chronic kidney disease (CKD) and periodontitis share a bidirectional inflammatory relationship, with cytokines such as IL-6, TNF-α, and hsCRP driving progression in both conditions. Non-surgical periodontal therapy (NSPT) has shown reductions in systemic inflammatory markers with emerging evidence of improved renal function, yet robust randomized controlled trials targeting pre-dialysis stage IV-V diabetic CKD patients remain lacking. In the Indian context, where diabetes-related CKD is rapidly rising and access to dialysis is limited, there is a clear lacuna in literature regarding the effectiveness of NSPT in delaying progression to end-stage renal disease. Hence, the present non-randomized clinical study is undertaken to address this gap.",[29,234,417],"End Stage Renal Disease (ESRD)",[29,419,234,420,421],"Subgingival Instrumentation","End Stage Renal Disease","Dialysis","2026-06-16",{"date":353,"type":45},{"date":425,"type":22},"2026-07",{"date":427,"type":22},"2027-12",{"name":429,"class":52},"Postgraduate Institute of Dental Sciences Rohtak",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":88,"phases":438,"briefSummary":439,"conditions":440,"keywords":443,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":53},"100636992","phase-1-adia-med-of-winter-park-llc-chronic-kidney-disease-research-study-100636992","NCT07572890","Adia Med of Winter Park LLC Chronic Kidney Disease Research Study","Inclusion Criteria:\n\n* Age 18-80 years\n* Confirmed CKD diagnosis (eGFR 15-89 mL\u002Fmin\u002F1.73 m²)\n* Willingness to consider experimental treatments and comply with study requirements\n* Ability to obtain required bloodwork\n* Ability to attend all scheduled visits\n* Able to meet study cost requirements ($15,000 study fee) as described in the informed consent\n\nExclusion Criteria:\n\n* Has\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Immunocompromised\n* Malignancy history\n* Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion\n* Current dialysis (hemodialysis or peritoneal dialysis) or planned initiation of dialysis during the study period\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days\n* Has had Kidney transplant\n* Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening","80 Years",{"count":207,"type":22},[90],"The goal of this clinical trial is to learn whether a new regenerative treatment called AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with glutathione, is safe and can help improve kidney function in adults with chronic kidney disease (CKD). In this condition, the kidneys gradually lose their ability to filter blood as well as they should. The main questions it aims to answer are whether AdiaVita plus glutathione improves kidney function better than control treatments, as measured by blood tests for estimated glomerular filtration rate (eGFR) and creatinine levels, and whether the treatment is safe with acceptable side effects. Researchers will compare three groups. One group will receive AdiaVita plus glutathione. A second group will receive glutathione plus a placebo for AdiaVita. The third group will receive placebos for both treatments. A placebo looks like the real treatment but contains no active ingredients. This will help determine if the full treatment works better than the controls. Approximately 100 adults aged 18 to 80 with stage 2 to 4 chronic kidney disease may participate. Participants will be randomly assigned to one of the three treatment groups. They will receive monthly intravenous infusions at the clinic for the first three months and apply a skin spray twice daily at home during that period. The study lasts 12 months total for each participant, with regular visits for blood tests, physical exams, and safety monitoring. Certain participants in the control groups may switch to the active AdiaVita treatment after three months if they meet safety criteria. This is a single-blind study, meaning participants will not know which treatment they receive. Participant safety is closely monitored by the research team and an independent board throughout the study.",[29,319,441,442,235],"Kidney Disease, Chronic","Chronic Kidney Disease (CKD)",[444,445,446,447,29,235,448,449,450],"allogeneic stem cells","antioxidant therapy","stem cell therapy","stem cells","Regenerative medicine","Glutathione","Glutathione therapy",{"date":395,"type":45},{"date":453,"type":22},"2026-05-18",{"date":455,"type":22},"2029-01",{"name":457,"class":52},"Adia Med of Winter Park LLC",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":466,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":88,"phases":469,"briefSummary":470,"conditions":471,"keywords":472,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":53},"100641143","inflammatory-cytokines-and-oxidative-stress-biomarkers-in-diabetic-chronic-kidney-disease-patients-100641143","NCT07657286","Inflammatory Cytokines and Oxidative Stress Biomarkers in Diabetic Chronic Kidney Disease Patients","Inflammatory Cytokines and Oxidative Stress Biomarkers Response to Life Style Modification in Diabetic Chronic Kidney Disease Patients","intervention","Inclusion Criteria:\n\n* sedentary lifestyle for at least three months prior to enrollment\n* body mass index (BMI) of 30-35 kg\u002Fm².\n\nExclusion Criteria:\n\n* using tobacco\n* heart failure\n* coronary arteries\n* severe heart valve problems\n* pregnant\n* liver inflammation\n* kidney transplant\n* physical injuries restricting them from exercising\n* utilization of anti-inflammatory medications","36 Years","58 Years",{"count":261,"type":22},[175],"This research intends to analyze how a 12-week adjustment in lifestyle influences inflammatory cytokines and oxidative stress indicators in overweight individuals diagnosed with type 2 diabetes and moderate CKD",[29,124],[473],"Diabetes; Weight Reduction; Oxidative Stress; Cytokines; Obesity.","2026-06-14",{"date":353,"type":45},{"date":477,"type":45},"2026-06-07",{"date":479,"type":22},"2026-09-07",{"name":481,"class":52},"Badr University",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":490,"targetDuration":4,"studyType":88,"phases":492,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":512},"100604778","pivotal-study-of-the-velocity-pavf-system-100604778","NCT07153939","Pivotal Study of the Velocity™ pAVF System","Multicenter Pivotal Study of the Velocity™ Percutaneous Arterio-Venous Fistula System","VENOS-3","Inclusion Criteria:\n\n1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months\n2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm\n3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm\n4. Age \\> 18 years and \\\u003C 80 years\n5. Willing and competent to give written informed consent\n6. Willing and able to complete all study assessments and follow-up requirements\n\nExclusion Criteria:\n\n1. Study extremity systolic blood pressure \\\u003C 100mmHg\n2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test\n3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.\n4. Distance between Cubital Perforating Vein and Proximal Radial Artery \\> 3.0 mm\n5. Cephalic vein diameter \\\u003C 2.5 mm at any point from the CPV to the axillary vein\n6. Central venous occlusion ipsilateral of the study extremity\n7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.\n8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days\n9. History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina\n10. Any contraindication to antiplatelet therapy\n11. Currently being treated with another investigational device or drug\n12. Known adverse effects to sedation and\u002For anesthesia which cannot be adequately pre-medicated\n13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \\> 10%\n14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder\n15. Lymphedema of the study extremity\n16. Scheduled kidney transplant within 6 months of enrollment\n17. Peripheral white blood cell count \\\u003C 1,500 cells\u002FμL or \\> 13,000 cells\u002FμL and neutrophil \\> 80%\n18. Platelet count \\\u003C 75,000 cells\u002F μL\n19. Current diagnosis of carcinoma (unless in remission \\> 1 year)\n20. Pregnant or currently breast feeding\n21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System\n22. Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data\n23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.",{"count":491,"type":22},126,[175],"This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used.\n\nThe Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis.\n\nThe study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years.\n\nTaking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.",[29,495,496,417],"Hemodialysis Access","Arteriovenous Fistula",[498,499,500,501,496,502,488,503],"percutaneous AVF","pAVF","endovascular AVF","endoAVF","AVF","VENOS3","2026-06-13",{"date":422,"type":45},{"date":507,"type":45},"2025-10-21",{"date":509,"type":22},"2030-09",{"name":511,"class":76},"Venova Medical",12,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":53},"100610819","an-observational-study-called-fine-real-korea-to-learn-more-about-the-use-of-the-drug-finerenone-in-people-with-chronic-kidney-disease-and-type-2-diabetes-in-a-routine-medical-care-setting-in-south-korea-100610819","NCT07232537","An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea","FINE-REAL Korea: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting in Korea","Inclusion Criteria:\n\n* Adult female or male participant - All genders (≥18 years old)\n* Diagnosis of CKD associated with T2D based on assessment by physician\n* Treatment according to local marketing authorization, finerenone 20 or 10 mg. Treatment should have been started up to 8 weeks before or after the ICF is signed.\n* Decision to initiate treatment with finerenone must be made before ICF is signed\n\nExclusion Criteria:\n\n* Participation in an investigational trial at any time during the course of this study\n* Contra-indications according to the local label",{"count":148,"type":22},"This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone are collected and studied.\n\nChronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and extra water from the blood. Type 2 diabetes occurs when the body does not produce enough insulin or does not use it effectively, leading to high blood sugar levels that can harm the kidneys. As a result, CKD can develop as a complication of T2D.\n\nThe study drug, finerenone, is already approved for doctors to prescribe to patients with CKD and T2D.\n\nFinerenone is a medication that works by blocking certain proteins known as mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse.\n\nThe main purpose of this study is to learn more about characteristics and treatment patterns of people with CKD and T2D who have recently started or will start finerenone treatment as prescribed by their doctor as part of their routine medical care in South Korea.\n\nThe FINE-REAL Korea study is designed to collect additional data on people with CKD and T2D who are treated with finerenone according to the approved product information, and it will work alongside the original FINE-REAL study (NCT05348733) to gather enough information for safety assessments in Korean population.\n\nTo achieve this, researchers will collect data on:\n\n* Clinical characteristics of participants, including their medical history related to CKD and T2D, blood pressure, and heart health.\n* Reasons for starting finerenone.\n* Reasons for stopping finerenone early.\n* The planned and actual duration of finerenone treatment.\n* The dosing of finerenone.\n* Other medications taken alongside finerenone.\n\nThe study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.\n\nOne specific concern is hyperkalemia, which refers to high potassium levels in the blood. This condition can occur when finerenone is used with certain blood pressure medications. Researchers want to understand how often hyperkalemia happens and whether it leads to:\n\n* Early discontinuation of finerenone treatment.\n* The need for dialysis, a procedure that filters waste from the blood.\n* Hospitalization for care.\n\nData for this study will be collected from medical records and through interviews conducted by study doctors during routine medical visits.\n\nParticipants will be involved in the study for up to 12 months, although this duration may be shorter if their finerenone treatment is stopped early.",[29,151],"2026-06-12",{"date":525,"type":45},"2026-06-15",{"date":527,"type":45},"2025-11-20",{"date":529,"type":22},"2028-01-28",{"name":162,"class":76},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":88,"phases":541,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":53},"100642082","early-phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ctx001-in-healthy-adults-100642082","NCT07577817","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.","A Phase 1, 3-Part, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of CTX001 in Healthy Adult Participants.","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Agrees to use effective contraception\n* Body Mass Index (BMI) between 18.0 and 32.0 kg\u002Fm2\n* Healthy by medical evaluation and medical history\n* Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20%\n* Can swallow tablets and has suitable venous access for blood sampling\n\nExclusion Criteria:\n\n* Has dietary requirements that may be difficult to accommodate\n* Is a regular user of cannabis or has a history of illicit drug abuse within 1 year\n* Has a history of alcohol abuse or binge drinking within 6 months\n* Is a regular user of tobacco or nicotine-containing products\n* Unwilling or unable to comply with the lifestyle guidelines described in the protocol\n* Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator\n* Has any concurrent disease or condition or physical, psychological, mental, and\u002For social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study\n* Has received a blood transfusion within 1 year\n* Has donated whole blood within 6 months or plasma within 30 days\n* Requires prescription medication or regular use of non-prescription medication\n* Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study","55 Years",{"count":540,"type":22},72,[542],"EARLY_PHASE1","This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and\u002For food.",[349,545,29],"Iron Deficiencies",[547,548,349,549],"Red blood cells","Iron","Chronic kidney disease","2026-06-10",{"date":523,"type":45},{"date":553,"type":22},"2026-06",{"date":555,"type":22},"2026-12-30",{"name":557,"class":76},"Cajal Therapeutics Inc.",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":578,"leadSponsor":580,"locationsCount":4},"100642349","clinical-study-on-a-new-diagnostic-strategy-for-osteoporosis-and-sarcopenia-in-chronic-kidney-disease-patients-based-on-mri-ff-100642349","NCT07645794","Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF","A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR","Inclusion Criteria:\n\n1. Age between 18 and 80 years old.\n2. Able to understand and sign the informed consent form.\n3. Able to complete MRI-FF scans of the lumbar spine and thigh.\n4. For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m² for ≥3 months).\n5. For control group: No history of chronic kidney disease and normal renal function.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia).\n2. History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.\n3. Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).\n4. Severe lower limb deformity or amputation affecting thigh muscle assessment.\n5. Inability to cooperate with the scan due to cognitive impairment or severe illness.",{"count":566,"type":22},868,"This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.",[29,569],"Osteoporosis",[29,569,571,572,573,574],"Sarcopenia","MRI-FF","Bone Mineral Density","Muscle Fat Fraction","2026-06-09",{"date":523,"type":45},{"date":553,"type":22},{"date":579,"type":22},"2028-12",{"name":581,"class":52},"Capital Medical University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":88,"phases":591,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":601,"locationsCount":603},"100642270","phase-2-a-phase-ii-clinical-trial-of-efficacy-and-safety-of-sal0140-at-different-doses-in-patients-with-chronic-kidney-disease-100642270","NCT07647133","A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SAL0140 at Different Doses in Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n1. Aged ≥18 years , regardless of gender.\n2. Diagnosed with chronic kidney disease (CKD)\n3. Urine albumin-creatinine ratio (UACR) of ≥300 mg\u002Fg and ≤5000 mg\u002Fg.\n4. Serum potassium≥ lower limit of normal (LLN) and ≤4.8 mmol\u002FL.\n5. Receiving stable background concomitant medication at screening\n6. Mean seated office systolic blood pressure (msSBP) ≥120 mmHg.\n7. Morning serum cortisol \\>3 μg\u002FdL.\n8. Voluntarily participate in the trial and provide written informed consent.\n9. Agree to comply with trial contraception and reproductive restrictions.\n\nExclusion Criteria:\n\n1. Had a documented diagnosis of autosomal dominant polycystic kidney disease or chronic kidney disease associated with infection or malignancy.\n2. Had acute kidney injury or end-stage renal disease, received peritoneal dialysis, hemodialysis or kidney transplantation; or planned to undergo kidney transplantation or chronic renal replacement therapy during the study period.\n3. Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and\u002For mean seated office diastolic blood pressure (msDBP) ≥110 mmHg. History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.\n4. History or diagnostic evidence of other secondary hypertension.\n5. Serum sodium \\\u003C135 mmol\u002FL .\n6. Subjects with severe hepatobiliary diseases.\n7. Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).\n8. Receiving blood transfusion for anemia.\n9. Poorly controlled diabetes mellitus.\n10. Morbid obesity.\n11. Had cardiovascular disease that precludes participation in the study or any electrocardiogram (ECG) abnormalities deemed by the investigator to substantially increase the subject's risk.\n12. History of adrenal insufficiency.\n13. History of solid organ or bone marrow transplantation.\n14. Medication compliance \\\u003C80% or \\>120%.\n15. History of acute diabetic complications.\n16. Prior exposure to rituximab or cytotoxic chemotherapeutic agents.\n17. Prior exposure to systemic immunosuppressive drugs.\n18. Recent use of traditional Chinese medicine (TCM) or proprietary Chinese preparations indicated for urinary protein reduction.\n19. Recent use of strong CYP3A inhibitors or CYP3A inducers.\n20. Active malignancy or past medical history of malignant tumor.\n21. Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.\n22. History of substance abuse or chronic alcohol abuse.\n23. Recent blood donation or major blood loss (\\>400 mL), or clinically diagnosed hypovolemia.\n24. Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.\n25. Participation in any other clinical trial and receipt of an investigational product within 3 months.\n26. Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.\n27. Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and\u002For safety assessment.",{"count":590,"type":22},249,[592],"PHASE2","This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).",[29],[29,596,597],"Aldosterone Synthase Inhibitor","Renin",{"date":525,"type":45},{"date":525,"type":22},{"date":250,"type":22},{"name":602,"class":76},"Shenzhen Salubris Pharmaceuticals Co., Ltd.",2,{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":88,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":4},"100643172","lifestyle-intervention-in-ckd-100643172","NCT07633145","Lifestyle Intervention In CKD","Multi-component Lifestyle Intervention to Improve Outcomes in Chronic Kidney Disease","CKD-LIFE","Inclusion Criteria:\n\n* Black race; ≥18 years old\n* history of hypertension\n* SBP ≥120 or DBP ≥80 mm Hg average of three measurements at screening visit (per KDIGO recommended SBP target of \\\u003C120 mm Hg)48\n* Stable anti-hypertensive medication regimen (i.e., no medication changes 4 weeks prior to enrollment);\n* eGFR of 15-44 ml\u002Fmin\u002F1.73m2 at screening visit\n* agreeable to randomization to either of the 2 study arms\n\nExclusion Criteria:\n\n* currently receiving or needing dialysis; having received or needing a kidney transplant\n* acute kidney injury at time of screening\n* average SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg at screening\n* Exaggerated systolic response during ETT (e.g., SBP \\>210 mmHg in men or \\>190 mmHg in women)\n* underweight (BMI \\\u003C18.5 kg\u002Fm2)\n* planned weight loss surgery in 1 year\n* a score of 27 or higher on the BP medication adherence scale\n* cardiac condition that would preclude participation in aerobic exercise training, including severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at \\\u003C85% heart rate reserve on screening treadmill testing), severe heart failure (NYHA Class 3 or 4), high grade arrhythmias, severe valvular heart disease\n* severe asthma or chronic obstructive lung disease\n* musculoskeletal or neurologic conditions that would preclude participation in aerobic exercise training\n* a major psychiatric disorder\n* illicit drug abuse\n* current alcohol consumption \\>14 drinks\u002Fweek for men and \\>7 drinks\u002Fweek for women\n* pregnant or planned pregnancy within 1 year\n* gastric bypass surgery within the last 2 years\n* a life-limiting comorbid medical condition, such as cancer.\n* physical limitation, gait instability, or need for continuous weight-bearing support that, in the opinion of study staff, would prevent safe completion of exercise treadmill testing",{"count":613,"type":22},152,[175],"This research study will test whether a 12-week healthy lifestyle program offered through a cardiac rehabilitation center can help lower blood pressure and improve kidney health in adults with advanced chronic kidney disease. Participants will be randomly assigned to either routine kidney health education or take part in a program that includes healthy eating guidance, supervised exercise sessions, and wellness coaching. The goal of the study is to determine whether this program can improve blood pressure and other factors linked to worsening kidney disease.",[29,179],[618,619,620,621,622,623,624,625],"chronic kidney disease","blood pressure","lifestyle intervention","diet","exercise","weight management","cardiac rehabilitation","hypertension","2026-06-08",{"date":550,"type":45},{"date":629,"type":22},"2026-07-14",{"date":631,"type":22},"2030-06-30",{"name":633,"class":52},"Duke University",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":88,"phases":643,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":53},"100643658","phase-1-a-study-of-ono-3310-in-healthy-adult-male-subjects-and-chronic-kidney-disease-patients-with-type-2-diabetes-mellitus-100643658","NCT07619157","A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus","A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\nHealthy adult part\n\n1. Japanese healthy adult male subjects\n2. Age at the time of informed consent: 18 to 45\n3. BMI (at screening): 18.5 kg\u002Fm2 to less than 25.0 kg\u002Fm\\^2\n\nChronic kidney disease patient part\n\n1. Chronic kidney disease patients with type 2 diabetes mellitus\n2. Age at the time of informed consent: 18 to less than 65\n3. UACR measured by 24-hour urine collection: 300 mg\u002Fg to less than 3500 mg\u002Fg\n\nExclusion Criteria:\n\nHealthy adult part\n\n1. Subjects who currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, or endocrine function.\n2. Presence or history of severe allergy to drugs or food\n3. Presence or history of drug or alcohol dependence\n\nChronic kidney disease patient part\n\n1. Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease\n2. Patients with type 1 diabetes mellitus\n3. Patients with a history of dialysis treatment","64 Years",{"count":290,"type":22},[90],"To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and chronic kidney disease patients with type 2 diabetes mellitus",[646,29],"Type2 Diabetes Mellitus","2026-06-04",{"date":626,"type":45},{"date":650,"type":45},"2026-06-02",{"date":652,"type":22},"2027-11-30",{"name":654,"class":76},"Ono Pharmaceutical Co., Ltd.",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":88,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":671,"leadSponsor":673,"locationsCount":53},"100643819","investigating-vascular-properties-of-hemi-and-spg-signals-in-individuals-with-or-at-risk-for-chronic-kidney-disease-100643819","NCT07604922","Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease","STIMULUS-CKD","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  * Adults aged over 18 years, of both sexes\n  * Patients eligible for or affiliated with a social security scheme\n  * Patients who have provided written informed consent to participate in the study\n\nCommon Exclusion Criteria:\n\n* Inability to give informed consent\n* Persons under legal protection (guardianship, trusteeship, or court protection)\n* Language barrier or psychological refusal to read the information\n* Medical conditions with a life expectancy \\\u003C 1 year according to clinical judgment\n* Ongoing participation restriction due to another clinical research study\n* Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)\n* Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block\n\nExclusion Criteria:\n\n* Hypertension Group\n\n  * Inclusion: Prior diagnosis of arterial hypertension\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol\n    * Type 2 diabetes Type 2 Diabetes Group\n  * Inclusion:\n  * Prior diagnosis of type 2 diabetes\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C 60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol Moderate CKD Group\n  * Inclusion:\n  * Moderate CKD (eGFR between 30 and 60 mL\u002Fmin) (CKD-EPI)\n  * Patients scheduled for arterial stiffness assessment as part of routine care\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n  * No specific exclusion criteria beyond common exclusions Severe CKD Group\n  * Inclusion:\n\n    * Severe CKD (GFR \\\u003C 30 mL\u002Fmin for ≥ 2 months)\n    * Patients scheduled for arterial stiffness assessment as part of routine care\n    * Stable cardiovascular treatment the previous 1 month\n  * Exclusion: No specific exclusion criteria beyond common exclusions20 \u002F 48 C25-07\\_Protocole\\_ V1.0\\_01.12.2025 Healthy Volunteers Group\n  * Inclusion: No documented chronic disease\n  * Exclusion:\n\n    * Moderate or severe CKD (GFR \\\u003C 60 mL\u002Fmin) (CKD-EPI)\n    * Hypertension\n    * Type 2 diabetes\n    * Stable cardiovascular treatment in the previous 1 month",{"count":663,"type":22},165,[175],"This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.",[29,667,668],"Hypertension (HTN)","Type 2 Diabetes Mellitus (T2DM)",{"date":626,"type":45},{"date":525,"type":22},{"date":672,"type":22},"2028-09-15",{"name":674,"class":675},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV"]