[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-diseaseckd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-diseaseckd":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,50,67,104,126,152,179,202,231,266,302,329,364,390,411,436,458,483,505,529,550,571,598,621,645],{"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":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100585766","implementation-program-to-improve-screening-and-management-for-ckd-in-diabetes-iris-ckd-program-2-100585766",false,"NCT06906640","Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)","Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)","IRIS-CKD","Inclusion Criteria:\n\n* (CKD Management)\n\n  * Adults with type 2 diabetes (T2D)\n  * Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)\n  * Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):\n\n    * UACR \\>300 mg\u002Fg or\n    * eGFR \\\u003C45 ml\u002Fmin\u002F1.73 m2 or\n    * UACR ≥30 mg\u002Fg with eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2\n  * Receiving \\\u003C100% GDMT at baseline. For patients with UACR \\\u003C30 mg\u002Fg, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi\u002FARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).\n\nExclusion Criteria:\n\n* (CKD Management)\n\n  * Type 1 diabetes\n  * Most recent eGFR \\\u003C20 ml\u002Fmin\u002F1.73 m2\n  * Prior kidney transplant\n  * Autosomal dominant polycystic kidney disease (ADPKD)\n  * Active pregnancy or plans for conception within 1 year","ALL","18 Years",{"count":21,"type":22},420,"ESTIMATED","INTERVENTIONAL",[25],"NA","IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.",[28,29,30],"Chronic Kidney Disease(CKD)","Type 2 DM","Type 2 Diabetes Mellitus (T2DM)",[32,33,34,35,36],"CKD","T2DM","T2D","Type 2 Diabetes","Chronic kidney disease","RECRUITING","2026-06-15",{"date":40,"type":41},"2026-06-16","ACTUAL",{"date":43,"type":41},"2025-10-28",{"date":45,"type":22},"2027-04-01",{"name":47,"class":48},"Duke University","OTHER",7,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":16,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":49},"100585765","implementation-program-to-improve-screening-and-management-for-ckd-in-diabetes-program-1-iris-ckd-100585765","NCT06906627","Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)","Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD)","Screening Program-\n\nInclusion Criteria:\n\n* Adults with type 2 diabetes (T2D)\n* Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP).\n* Lack of estimated glomerular filtration rate (eGFR) and\u002For urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR\n\nExclusion Criteria:\n\n• Chronic kidney disease (CKD) diagnosis",{"count":58,"type":22},750,[25],"IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.",[28,29,30],[32,33,34,35,36],{"date":40,"type":41},{"date":43,"type":41},{"date":45,"type":22},{"name":47,"class":48},{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100599366","routine-validation-and-reproducibility-testing-of-laboratory-assays-and-research-techniques-used-for-endocrine-cardiometabolic-and-musculoskeletal-disorder-research-vald-100599366","NCT07083557","Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)","VALD","Inclusion Criteria:\n\n* ≥18 and ≤100 years of age\n* body mass index ≥16.0 and ≤60 kg\u002Fm2\n\nExclusion Criteria:\n\n* \\\u003C18 and \\>100 years of age\n* body mass index \\\u003C16.0 or \\>60 kg\u002Fm2\n* allergies, intolerances, or dietary restrictions to meal ingredients, vegans or vegetarians\n* use of medications or dietary supplements (e.g., anti-inflammatories, immune modulators, etc) that could interfere with the particular assay\u002Ftechniques being evaluated\n* engaged in regular structured exercise \\>150 min per week unless needed for validation of the assay\u002Ftechnique being evaluated\n* significant organ system dysfunction or diseases, except those that are sought for validation of the assay\u002Ftechnique being evaluated\n* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances unless alcohol use disorder is required for validation of the assay\u002Ftechnique being evaluated\n* pregnant women, persons who smoke, prisoners, and inability to grant voluntary informed consent.",true,"100 Years",{"count":77,"type":22},100,"OBSERVATIONAL","The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases, nutrition, and metabolism (the process by which a substance is handled in the body) at the University of Missouri. As technology changes and uses new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure the results are accurate. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. This study will look at the validation and reproducibility of tests and laboratory assays in participants who are healthy or affected by relevant endocrine, cardiometabolic, and musculoskeletal disorders.",[81,82,83,84,85,86,87,88,89,90,91,28,92,93],"Obesity and Obesity-related Medical Conditions","Diabetes","Atherosclerotic Disease","Heart Failure","MASH","Sarcopenia","Osteoporosis","Hyperparathyroidism","Hypoparathyroidism","Ischemic Heart Disease","Cystic Fibrosis (CF)","Osteopenia","Cachexia","2026-05-05",{"date":96,"type":41},"2026-05-07",{"date":98,"type":22},"2027-01-01",{"date":100,"type":22},"2030-07-01",{"name":102,"class":48},"Bettina Mittendorfer",1,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":74,"sex":18,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100561842","kidney-function-in-people-with-cystic-fibrosis-in-the-era-of-hemt-100561842","NCT06595420","Kidney Function in People With Cystic Fibrosis in the Era of HEMT","Inclusion Criteria:\n\n1. Outpatient CF Cohort\n\n   * Diagnoses of Cystic Fibrosis\n   * Age \\> 30 years old\n   * Able to provide informed consent\n2. Inpatient CF Cohort\n\n   * Diagnoses of Cystic Fibrosis\n   * Age \\> 7 years old\n   * Able to provide informed consent and assent (where applicable)\n   * 55 PwCF frequently hospitalized for a pulmonary exacerbation (\\>1 hospital admission in the prior 12 months)\n   * 55 PwCF sporadically hospitalized for a pulmonary exacerbation (no hospital admissions in the prior 12 months)\n   * Able to provide urine sample independently\n3. Healthy Controls\n\n   * Healthy, as per participant self-report\n   * Age between 30-50 years\n   * Able to provide informed consent\n\nExclusion Criteria:\n\n1. Outpatient CF Cohort\n\n   * History of any organ transplant\n   * History of immunodeficiency\n   * Previous or current cancer diagnoses\n   * Pregnant or breastfeeding\n   * On chronic dialysis\n   * Non-compliance (demonstrated by \\<2 visits during the 12 months before enrollment)\n2. Inpatient CF Cohort\n\n   * The initiation of intravenous antibiotic therapy after hospital admission before obtaining the first blood and urine sample\n   * History of any organ transplant\n   * History of immunodeficiency\n   * Previous or current cancer diagnoses\n   * Pregnant or breastfeeding\n   * On chronic dialysis\n3. Healthy Controls\n\n   * History or current kidney disease, organ transplantation, cancer, or any other chronic illness\n   * Current use of antibiotics\n   * Urinary symptoms or UTI (dysuria, frequency, urgency)\n   * Pregnant women\n   * Menstruating on the study visit day\n   * Blood relatives of PwCF","7 Years",{"count":112,"type":22},260,"The purpose of this study is to find out what causes kidney disease in people with CF. The investigators will study biomarkers in the blood and urine that can either predict who is at risk or detect kidney damage early before it becomes permanent. The study will compare these markers in people with CF over time and during the treatment of lung flare-ups. It will also compare the blood and urine samples obtained from people without CF. The comparison aims to better understand the impact of cystic fibrosis and its treatment on the kidneys, as well as to develop improved methods for preventing, diagnosing, and treating kidney issues associated with CF.",[91,28,115],"Acute Kidney Injury","2026-04-27",{"date":118,"type":41},"2026-05-04",{"date":120,"type":41},"2025-01-09",{"date":122,"type":22},"2027-12",{"name":124,"class":48},"University of Virginia",3,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":103},"100574053","an-intervention-to-reduce-sedentary-behavior-for-adults-with-chronic-kidney-disease-100574053","NCT06754280","An Intervention to Reduce Sedentary Behavior for Adults With Chronic Kidney Disease","An Intervention to Reduce Sedentary Behavior for Adults With Chronic Kidney Disease: RESET-CKD","RESET-CKD","Inclusion Criteria:\n\n* Self-identifies as Black or African American\n* Age ≥35 to ≤80 years old\n* CKD Stage 1-4\n* Self-reported 6 or more hours\u002Fday of sedentary time\n* Ability to speak\u002Fread\u002Funderstand English\n* Has access to a telephone\n\nExclusion Criteria:\n\n* Being unable to walk 1 block\n* Being unable to stand from a seated position without assistance\n* Using a wheelchair, walker, or cane for all of their ambulation\n* Presence of a condition(s) or diagnosis, either physical or psychological, that precludes participation, including: Lower-extremity amputation (AKA or BKA) without prosthetic, Orthopedic condition that would preclude prompted sit-to-stand transitions or standing, Neurologic or psychiatric condition that would preclude prompted sit-to- stand transitions or standing, Severe cognitive impairment, Unstable coronary artery disease (i.e., angina with activity), Orthostatic hypotension\n* Kidney transplant\n* Any other condition that the investigator considers precludes participation in the trial\n* Participated in the Patient Advisory Board","35 Years","80 Years",{"count":137,"type":22},40,[25],"RESET-CKD is evaluating an intervention to support Black adults with chronic kidney disease (CKD) to reduce their sedentary (e.g., sitting) time. Half of the participants will be randomized to the intervention, where the goal is to support individuals to reduce their sitting time, and the other half will be randomized to an attention control condition that provides CKD-related education not related to sedentary behavior. All participants will be followed for 12 weeks.",[28],[142],"Sedentary","2026-02-19",{"date":145,"type":41},"2026-02-23",{"date":147,"type":41},"2025-03-13",{"date":149,"type":22},"2027-05",{"name":151,"class":48},"University of Illinois at Chicago",{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":103},"100569774","memri-and-kidney-disease-100569774","NCT06698614","MEMRI and Kidney Disease","Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) in Patients With Kidney Disease","Inclusion Criteria:\n\nAll subjects to be entered must:\n\nBe able to provide written informed consent after having received oral and written information about the study.\n\n\\>18 years of age Availability to complete study visits If female, be non-pregnant as evidenced by a negative pregnancy test or be post-menopausal or surgically sterile.\n\nAdditionally, cohort specific inclusion criteria are as follows:\n\nCohort 1; Acute kidney injury-\n\nA diagnosis of AKI will be made based on the following criteria (based on the definition used in the Kidney Precision Medicine Project www.kpmp.org):\n\nPrevious (within 3 years) eGFR \\>45 ml\u002Fmin\u002F1.73m2 OR no history of kidney disease if no blood results available AND Elevated creatinine \\>1.5x previous result OR \\>150 μmol\u002FL if no previous value AND Increasing creatinine within 48 hours OR requirement for dialysis.\n\nCohort 2; Chronic kidney disease- Stable CKD for at least 6 months (monitored by eGFR), matched to AKI cohort at follow up based on renal function.\n\nCohort 3: Matched controls- Matched to AKI cohort participants at baseline for age, sex, cardiovascular disease risk and cardiovascular medication.\n\nCohort 4; Vasculitis- A new diagnosis of vasculitis or an existing diagnosis with relapsing disease, and kidney involvement.\n\nCohort 5; Kidney transplantation- Has kidney failure and has received a kidney transplant in the preceding 1 month.\n\nCohort 6: Kidney transplant rejection- Biopsy proven episode of transplant rejection.\n\nExclusion Criteria:\n\nThe following criteria apply to all patients:\n\n1. Unable to give informed consent.\n2. Have any contraindications to standard MRI safety criteria, including implanted devices.\n3. Subjects under the age of 18 years old.\n4. Pregnancy\u002Fpositive pregnancy test.\n5. Current breastfeeding.\n6. Have a diagnosis of kidney disease due to polycystic kidney disease.\n7. Patients in critical care or on surgical wards will be excluded.\n8. Patients taking calcium channel antagonists or digoxin.\n\nAdditionally, cohort specific exclusion criteria are as follow:\n\nCohort 1- Excluded if they have a diagnosis of diabetes. Cohort 2- Excluded if receiving dialysis or those with a functional kidney transplant, multi-system disorders (e.g., systemic vasculitis), or any patients receiving immunosuppression.",{"count":160,"type":22},120,"Acute kidney injury (AKI) is common and costly.1 Although patients who suffer an episode of AKI may recover, many will go on to develop cardiovascular disease and chronic kidney disease (CKD). Cardiovascular disease is an important complication of AKI.2 Similar to AKI, CKD and kidney transplantation and kidney donation associations with cardiovascular disease.1 The risk of cardiovascular disease complications is also increased in patients with inflammatory diseases that affect the kidneys, such as vasculitis.\n\nCurrently, there are no reliable biomarkers that will identify those patients with kidney disease that will go on to develop cardiovascular disease. This study will explore the potential of manganese-enhanced magnetic resonance imaging (MEMRI) to act as a biomarker of AKI and its cardiovascular and renal complications. An analogue of calcium, manganese is readily taken-up into viable cells where it increases T1 relaxivity. Preliminary data show rapid manganese uptake in the heart and kidneys of healthy subjects.\n\nThe investigators propose to use MEMRI to demonstrate differences in renal and myocardial calcium handling in patients with acute insults (such as AKI, transplant rejection, donation or episodes of rejection or new vasculitis presentations) or improvements (such as transplantation). The investigators will also investigate whether these abnormalities reverse in those whose injury resolves or persist in those who clearly develop CKD, or who are at risk of future cardiovascular disease and CKD.",[115,163,164,28],"Kidney Transplant","Vasculitis",[166,167,168,169],"manganese enhanced magnetic resonance imaging","kidney disease","MEMRI","Manganese enhanced MRI","2025-12-01",{"date":172,"type":41},"2025-12-08",{"date":174,"type":41},"2024-11-07",{"date":176,"type":22},"2029-11-07",{"name":178,"class":48},"University of Edinburgh",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":137},"100495555","phase-3-intensification-of-blood-pressure-lowering-therapeutics-based-on-diuretics-versus-usual-management-for-uncontrolled-hypertension-in-patients-with-moderate-to-severe-chronic-kidney-disease-100495555","NCT05732727","Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease","Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease: an Open Label, a Cluster Randomized Controlled, Phase 3 Trial","THINK","Inclusion Criteria:\n\n* Male or female \\>=18 years with a clinical frailty score ≤5 for patient aged over 80\n* Advanced or moderate chronic kidney disease (eGFR 15 to 44.9 mL\u002Fmin\u002F1.73m² using CKD-EPI formula)\n* Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.\n* Uncontrolled office BP\n* Uncontrolled office BP (\\>140 and\u002For 90 mmHg) confirmed by home blood pressure monitoring (\\>135 and\u002For 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring\n* Participant covered by or entitled to social security\n* Written informed consent obtained from the participant\n\nExclusion Criteria:\n\n* Patient following any measures of legal presentation\n* Pregnant or breastfeeding woman\n* woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system)\n* Clinical signs of hypovolemia\n* Symptomatic orthostatic hypotension\n* Hyponatremia (\\\u003C130 mmol\u002FL)\n* Dyskalemia (\\\u003C3,5 mmol\u002FL or \\>5,5 mmol\u002FL)\n* Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke\n* Current medical history of cancer requiring chemotherapy\n* Solid organ transplantation\n* Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics)\n* Mineralocorticoid receptor antagonists\n* Autosomal dominant polycystic kidney disease treated with Tolvaptan\n* Contraindication to diuretics involved in the algorithm\n* Severe heart failure (NYHA III\\_IV)\n* Cirrhosis Child B-C",{"count":188,"type":22},720,[190],"PHASE3","Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. It's now well established that lowering blood pressure (BP) reduces renal and cardiovascular complications in this high-risk population. In the general population, in addition to lifestyle interventions, the strategy to initiate and escalate a BP-lowering drug treatment is well described. The drug therapies recommended to achieve optimal BP control in the general population are the following: blockers of the renin-angiotensin system (angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)), diuretics (thiazides and thiazide-like diuretics), and calcium channel blockers. For patients with CKD, the guidelines advise to start the BP-lowering agent with ACEi or ARB, but then, there is no strong evidence to support the preferential use of any particular agent in controlling BP and the results of clinical trials are discordant. In the NephroTest cohort, a French cohort of patients with CKD stage 1 to 5, among 2015 patients, 1782 had hypertension, only 54% had a diuretic and 44% had uncontrolled hypertension. In this cohort, extracellular fluid (ECF) overload was an independent determinant of hypertension, uncontrolled hypertension and apparent treatment resistant hypertension. In the same cohort, ECF overload was independently associated with end-stage kidney disease and death. Our hypothesis is that patients with CKD and uncontrolled hypertension are fluid overloaded and that the second line of treatment after an ACEi or an ARB should be a diuretic. We hypothesize that a specific algorithm to lower BP in patients with moderate to severe CKD based on diuretics will be more effective in term of cardiovascular event, mortality and evolution to end-stage kidney disease as compared to standard of care.",[28,193],"Uncontrolled Hypertension","2025-11-27",{"date":170,"type":41},{"date":197,"type":41},"2023-03-28",{"date":199,"type":22},"2029-03",{"name":201,"class":48},"University Hospital, Tours",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100611360","phase-4-a-biomarker-targeted-clinical-trial-to-optimize-treatment-for-patients-with-chronic-kidney-disease-100611360","NCT07239570","A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease","A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease: A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study","CKD-bioMatch","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years\n2. UACR 100-5000 mg\u002Fg (11.3-565 mg\u002Fmmol) in two consecutive first-morning void urine samples at screening. (UACR 80-100 mg\u002Fg is accepted if historical measurements are above 100 mg\u002Fg and if it cannot be explained by any new treatment.)\n3. Stable treatment with a maximum tolerated dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least four weeks prior to randomization. (Unless such treatment is contraindicated or not tolerated.)\n4. Ability to communicate with the study staff and understand and sign the informed consent.\n\nExclusion Criteria:\n\n1. eGFR \\\u003C 25 mL\u002Fmin\u002F1.73m2 at screening.\n2. Treatment with two or all three of the study drugs\n3. History of pancreatitis at screening\n4. Body mass index \\\u003C 18.5 kg\u002Fm2 at screening\n5. Type 1 diabetes\n6. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrollment\n7. NYHA class IV Congestive Heart Failure at screening\n8. Potassium \\> 5.0 mmol\u002FL at screening\n9. Addison's Disease\n10. Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)\n11. Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)\n12. Elevated Alanine Aminotransferase (ALT) \\> 3 x upper normal limit at screening, autoimmune hepatitis, and\u002For severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt).\n13. Autosomal dominant or autosomal recessive polycystic kidney disease\n14. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening\n15. Kidney transplant or dialysis\n16. Known or suspected hypersensitivity to the study medications or related products\n17. Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening.\n18. Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.\n19. A female who is pregnant, breastfeeding, or intends to become pregnant, or a woman of childbearing potential (WOCBP) who is not using highly effective contraceptive methods.\n20. Known or suspected abuse of narcotics.\n21. Participant in another intervention study.\n22. Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent).","75 Years",{"count":212,"type":22},125,[214],"PHASE4","Over 800 million people worldwide suffer from chronic kidney disease (CKD), which is associated with a high individual disease burden for those affected, multiple secondary diseases, frequent doctor contacts, and hospitalizations, but also outstanding costs for the health system and the solidarity community. Appropriate interventions are essential to prevent the development and progression of CKD. In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD. Sodium-glucose co-transporter 2 inhibitors, the non-steroidal mineralocorticoid receptor antagonist, finerenone, and the glucagon-like peptide-1 receptor agonist, semaglutide, have demonstrated albuminuria-lowering effects and kidney protection in people with CKD. Although these new pharmacological approaches show great promise, it is unclear how to optimally sequence and combine these therapies. In addition, the therapies are often not implemented due to treatment inertia and fear of adverse effects. This study aims to address this knowledge gap by utilizing a biomarker-guided treatment approach to reduce the decline in kidney function.\n\nThe aim of the CKD-bioMatch study is to evaluate the efficacy of a biomarker-targeted treatment approach versus standard of care in people with CKD and albuminuria. We hypothesize that a biomarker-targeted treatment approach is superior to standard of care at reducing estimated glomerular filtration rate (eGFR) decline in people with CKD.",[28],[218,219,220],"Chronic Kidney Disease","Personalized medicine","Biomarkers","2025-11-18",{"date":223,"type":41},"2025-11-20",{"date":225,"type":41},"2025-06-20",{"date":227,"type":22},"2028-06",{"name":229,"class":48},"Peter Rossing",4,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":251,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":103},"100606246","algae-effects-in-markers-of-cardiovascular-risk-and-gut-microbiome-100606246","NCT07173062","Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome","Algae Effects in Markers of Cardiovascular Risk and Gut Microbiome: a Placebo-controlled Randomized Double-blind Trial","CALGUT","Inclusion Criteria:\n\n* ≥50 years\n* BMI ≥20 kg\u002Fm2\n* History of stroke, coronary artery disease, myocardial infarction, peripheral artery disease, chronic kidney disease (eGFR \\\u003C75 ml\u002Fmin at least for 3 months), albuminuria \\>300 mg\u002Fg, or diabetes mellitus\n* No antibiotics in the previous 30 days\n* If a woman, she must be a woman of non-childbearing potential. That is, she must be:\n\n  * Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy);\n  * Clinically diagnosed infertile;\n  * In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.\n* A woman patient of childbearing potential must have a negative serum pregnancy test at Visit 0 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:\n\n  * Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject);\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);\n  * Intrauterine device;\n  * Intrauterine hormone-releasing system;\n  * Bilateral tubal occlusion;\n  * Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.\n\nExclusion Criteria:\n\n* Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign\u002Fcomplete the informed consent form on the patient's behalf).\n* Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n* Participation in another clinical study with an investigational product during the last month.\n* In participants recruited at Unidade Local de Saúde de São João, the exclusion criteria applied is estimated Glomerular Filtration Rate (eGFR) \\\u003C30 ml\u002Fmin\u002F1.73m2 estimated with the CKD-EPI (2021) formula or dialysis. For participants recruited at community, this exclusion criteria is adapted for diagnosis of end-stage renal disease or dialysis (no need to quantify the eGFR).","50 Years",{"count":241,"type":22},150,[25],"The Western diet, rich in fat and sugar, contributes to cardiovascular risk and alters the body metabolism, specifically through the modulation of the microbiome. Microbiome is considered the \"second genome\", functioning as an endocrine-like organ. Gut microbiota-derived metabolites, namely trimethylamine- N-oxide and short-chain fatty acids have been associated with atherosclerosis, vascular and cardiac diseases. Regarding trimethylamine- N-oxide, its association with cardiovascular disease is positive and dose-dependent. In contrast, short-chain fatty acids have been positively associated with the improvement of cardiovascular health.\n\nAlgae probiotics can modulate gut microbiome, stimulating the growth of commensal micro-organisms with health benefits. Previous studies suggested that Spirulina Arthrospira platensis supplementation could improve blood lipid levels and lower blood pressure, revealing anti-inflammatory and antioxidant roles. Other probiotics that could be beneficial to gut microbiota are macroalgae or seaweed. Macroalgae are a rich source of components which may prompt bacterial diversity and abundance.\n\nThe present prospective, randomized, three-armed parallel trial aims to generate good-quality evidence about the potential health effects and impact of Spirulina Arthrospira platensis (microalgae) and Gelidium corneum (macroalgae) supplements in humans. These participants will undergo 3 clinical evaluations: 2 before the beginning of micro- and macro-algae supplementation and the last one after 20 weeks of supplementation. The evaluation includes a vascular, nutritional and physical activity assessment, as well as blood, urine, saliva and stool collection for quantification of plasma biomarkers, oral and gut microbiota analysis, respectively.",[245,246,247,248,249,28,250],"Stroke","Coronary Arterial Disease (CAD)","Myocardial Infarction (MI)","Diabetes Mellitus","Peripheral Artery Disease (PAD)","Albuminuria",[252,253,254,255,256],"Spirulina Arthrospira platensis","Gelidium corneum","Trimethylamine- N-oxide (TMAO)","Short-Chain Fatty Acids (SCFA)","Cardiovascular risk (CVR)","2025-09-12",{"date":259,"type":41},"2025-09-15",{"date":261,"type":41},"2025-03-11",{"date":263,"type":22},"2026-08",{"name":265,"class":48},"Universidade do Porto",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":275,"studyType":78,"phases":4,"briefSummary":276,"conditions":277,"keywords":286,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":103},"100596262","cardiovascular-kidney-metabolic-syndrome-in-shanghai-zicitizens-100596262","NCT07043166","Cardiovascular-Kidney-Metabolic Syndrome in Shanghai Zicitizens","Epidemiological Survey and Follow-up of Cardiovascular-Kidney-Metabolic Diseases Among Adults in Shanghai","Inclusion Criteria:\n\n1. The 4,094 residents of Shanghai communities who have been enrolled in the STONE cohort.\n2. Individuals who completed the baseline questionnaire survey, physical examination, and related clinical tests between 2016 and 2017, with complete data records.\n3. Willingness to participate in this follow-up study and provision of informed consent.\n\nExclusion Criteria:\n\n1. Participants who have moved away from their original community and have been living elsewhere for more than two years.\n2. Participants whose contact information has changed or become invalid, resulting in loss of contact (those who remain uncontactable after three attempts to reach out).",{"count":274,"type":22},4094,"10 Years","The main purpose of this study is to conduct follow-up assessments and update the cardiorenal outcomes among the STONE cohort that was established during 2016-2017. The secondary aim is to compare metabolic risk factors, metabolic disturbances, and clinically relevant metabolic outcomes between the follow-up period and the baseline assessment. The exploratory goal is to examine the relationships between changes in risk factors and clinical outcomes in the participants.\n\nThe study is planned to begin in May 2025 and will finalize the data collection for the entire population by June 2026. During this time, participants will be categorized based on CKM staging. The follow-up phase will continue until 2035.",[278,82,279,280,281,282,283,28,284,285],"Metabolic Syndrome","Obesity and Overweight","Hypertension","Dyslipidemia","Thyroid Diseases","Bone Metabolism Disorder","Cardiovascular Diseases (CVD)","Cardiovascular-kidney-metabolic Syndrome",[287,288,289,290,291,292],"Cardiovascular-Kidney-Metabolic Syndrome","metabolic disorders","screening","risk factor","evaluation","prediction","2025-08-31",{"date":295,"type":41},"2025-09-08",{"date":297,"type":41},"2025-07-01",{"date":299,"type":22},"2035-12-31",{"name":301,"class":48},"Shanghai Changzheng Hospital",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":103},"100588362","prevalence-and-risk-factors-of-hyperkalemia-in-non-dialysis-chronic-kidney-disease-patients-in-community-100588362","NCT06940414","Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community","Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in a Community-Based Primary Care Setting","Inclusion Criteria:\n\n* Aged 18 years or older with stable vital signs, specifically defined as:\n\n  1. Body temperature: 36.0°C-38.0°C;\n  2. Pulse: 50-120 beats\u002Fmin;\n  3. Respiratory rate: 10-24 breaths\u002Fmin;\n  4. Blood pressure: Systolic blood pressure ≥90 mmHg and diastolic blood pressure ≥60 mmHg.\n* Willing to participate in the study and sign the informed consent form.\n* Hematocrit (Hct) level between 25% and 60%.\n* Confirmed diagnosis of chronic kidney disease (CKD).\n\nExclusion Criteria:\n\n* Patients in the unstable phase of acute cardiovascular or cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, or acute coronary syndrome).\n* Patients in the unstable phase of severe acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic coma).\n* Patients currently in the acute kidney injury (AKI) stage.\n* Patients who have started renal replacement therapy.\n* Pregnant or breastfeeding women.\n* Patients currently participating in or who have participated in other clinical trials within the past six months.\n* Patients unable to understand verbal or written instructions, including informed consent content.\n* Patients unable to cooperate with the study procedures.\n* Other conditions deemed unsuitable for participation in this clinical trial by the investigator.",{"count":310,"type":22},1890,"The goal of this observational study is to investigate the prevalence and risk factors of hyperkalemia in community-based non-dialysis chronic kidney disease (CKD) patients. The main questions it aims to answer are:\n\n1. What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting?\n2. What are the key risk factors influencing the occurrence of hyperkalemia in this population? Researchers will collect clinical and demographic data from participants across 18 community health centers and use both point-of-care testing (POCT) and laboratory-based methods to measure serum potassium levels and related parameters.\n\nParticipants will:\n\n1. Provide blood samples for POCT and laboratory testing.\n2. Participate in interviews or questionnaires to gather clinical and lifestyle information.\n\nThe findings will be used to construct a risk prediction model for hyperkalemia, aiming to optimize screening pathways and improve disease management strategies in primary care.",[313,28],"Hyperkalemia",[313,218,315,316,317,318],"Community-Based","Non-Dialysis","Prevalence","Eaglenos POCT System","2025-07-08",{"date":321,"type":41},"2025-07-11",{"date":323,"type":41},"2025-04-28",{"date":325,"type":22},"2025-09-30",{"name":327,"class":328},"Xiujuan Zang","OTHER_GOV",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":337,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":347,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":103},"100564641","the-effect-of-the-nutraceutical----epicatechin-on-myosteatosis-in-patients-with-advanced-ckd-100564641","NCT06631820","The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD","The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD: a Pilot Study (EPIC-CKD)","EPIC-CKD","Inclusion Criteria:\n\n* estimated glomerular filtration rate (eGFR) \\\u003C 29 ml\u002Fmin\u002F1.75m2\n* no chronic or acute known liver disease\n* not intended to initiate renal replacement therapy treatment in the next 4 months according to nephrologist clinical judgment\n\nExclusion Criteria:\n\n* signs of active infection\n* acute vasculitis\n* type 1 diabetes\n* use of steroids medication\n* transplanted patients\n* patients with deambulatory impairment (wheelchair users, bed rest)\n* patients on compassionate care for the end of life\n* with advanced neurological disorders\n* with cognitive impairments\n* with active cancer diagnosis\n* participation in another interventional trial.","60 Years",{"count":339,"type":22},10,[25],"Some foods have components that can prevent and treat some diseases and provide beneficial effects for health. These components naturally occurring in foods are called nutraceuticals. Recently, it was found that Epicatechin, which is a kind of nutraceutical from the Catechin's family naturally occurring in green tea and cocoa, has positive effects on muscle mass and strength of people with chronic diseases.\n\nPeople with chronic kidney disease often present muscle loss and lack of strength that are not easily treated with regular diet and physical activity. We here propose a study where 10 individuals with chronic kidney disease will receive a dose of Epicatechin for 8 weeks and we aim to test if Epicatechin improves general muscle health. Based on what is known, we expect to see an increase in muscle mass and strength.\n\nThe dose of Epicatechin provided (100 mg\u002Fday) is safe, since it is much lower than the dose usually available in supplements. In addition, this is the form naturally present in green tea and cocoa and in similar amounts. Subjects participating in the study will be evaluated for muscle mass and strength three times during the study. Muscle mass and muscle quality will be evaluated by ultrasound and magnetic resonance imaging. The participants will also perform some tests like walking in a corridor and seating and standing from a chair to measure their strength and performance. Adverse side effects will be monitored via telephone, and safety will be assessed by monthly blood tests that will evaluate liver and kidney function. If this study shows that Epicatechin can promote muscle growth and strength, it will positively affect patients with chronic kidney disease that might benefit of a natural substance from food to improve muscle health.",[28,343,344,345,346],"Myosteatosis","Mitochondrial Dysfunction","Muscle Function","Muscle Mass",[348,349,350,351,352,353,354],"myosteatosis","epicatechin","nutraceuticals","chronic kidney disease","mitochondrial dysfunction","muscle regeneration","muscle function","2025-07-07",{"date":357,"type":41},"2025-07-10",{"date":359,"type":41},"2025-01-17",{"date":361,"type":22},"2026-10",{"name":363,"class":48},"Karolinska Institutet",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":103},"100594569","phase-1-a-study-to-evaluate-the-safety-tolerability-and-pk-of-sk-08-100594569","NCT07021157","A Study to Evaluate the Safety, Tolerability and PK of SK-08","A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants","SK-08","Inclusion Criteria:\n\n1. Healthy male and female participants aged 18 to 45 years (inclusive).\n2. Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg\u002Fm².\n3. Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .\n4. Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Have a specific history of allergies or have an allergic constitution；\n2. Have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc.\n3. Developed acute diseases from 2 weeks before screening to before randomization ;\n4. Patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher;\n5. Those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia;\n6. Those who have used any drugs or health supplements from 2 weeks before screening to randomization ;\n7. Any drugs that may interact with this product have been used from 30 days before screening to randomization, such as CYP450 inhibitors or inducers ;\n8. Those who have undergone major surgical operations from 6 months before screening , or who plan to undergo surgery during the study period, or who have undergone surgeries as judged by the investigator to affect drug absorption, distribution, metabolism, and excretion;\n9. Those who have received live attenuated vaccine inoculation from 2 weeks before screening to randomization or those who need to receive live attenuated vaccine inoculation during the trial;\n10. Those who had a history of alcohol abuse within one year before screening；\n11. Those who smoked more than 5 cigarettes per day on average within 3 months before screening and before randomization, or were unable to stop using any tobacco products during the trial period;\n12. Those who cannot tolerate venipuncture\u002Findwelling needles or have a history of fainting from needles or blood ;\n13. Other researchers determined that the subjects were not suitable to participate.","45 Years",{"count":374,"type":22},48,[376],"PHASE1","The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.",[28],[28],"2025-06-18",{"date":382,"type":41},"2025-06-24",{"date":384,"type":41},"2025-03-09",{"date":386,"type":22},"2025-08-07",{"name":388,"class":389},"Consun Pharmaceutical Group","INDUSTRY",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":103},"100569462","monocytes-in-subjects-with-type-1-diabetes-and-chronic-kidney-disease-100569462","NCT06694558","Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease","Inclusion Criteria:\n\n1. T1D CKD subjects:\n\n   1. Adults, males or females diagnosed with T1D\n   2. Age 18-65 years\n   3. Diagnosed with CKD (eGFR 60-90 ml\u002Fmin\u002F1.73 m2)\n   4. Diagnosed with albuminuria (UACR 30-500 mg\u002Fg)\n   5. On insulin injections or pump\n   6. On CGM\n\n   Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\\\u003C60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\\>70% A1c 5.0-7.0\n2. Controls: T1D subjects without CKD\n\n   1. Adults, males or females diagnosed with T1D\n   2. Age 18-65 years\n   3. No CKD (eGFR \\>90 ml\u002Fmin\u002F1.73 m2)\n   4. No albuminuria (UACR \\\u003C30 mg\u002Fg)\n   5. On insulin injections or pump\n   6. On CGM\n\nBased on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\\\u003C60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\\>70% A1c 5.0-7.0\n\nExclusion Criteria:\n\n1. Hemoglobin \\\u003C9\n2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days\n3. pregnancy or plans to become pregnant\n4. On steroids\n5. Diagnosed with cancer, immunosuppression\u002Fautoimmune conditions\n6. Reported heavy alcohol use or recreational drug use\n7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion","65 Years",{"count":398,"type":22},60,"This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.",[28,401],"Type 1 Diabetes (T1D)","2025-06-10",{"date":404,"type":41},"2025-06-11",{"date":406,"type":41},"2025-03-01",{"date":408,"type":22},"2026-07-01",{"name":410,"class":48},"The Cleveland Clinic",{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":419,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":103},"100588656","ckm-syndrome-prevalence-and-its-association-with-score-2-and-bri-100588656","NCT06944236","CKM Syndrome Prevalence and Its Association With SCORE-2 and BRI","Prevalence of Cardiovascular-Kidney-Metabolic (CKM) Syndrome and Its Relationship With SCORE-2 Risk Score and Body Roundness Index (BRI): A Study From Gaziantep, Turkey","CKM-PREV","Inclusion Criteria Age between 30 and 79 years Residence in Gaziantep, Türkiye\n\nAvailability of the following laboratory tests performed within the past 1 month:\n\nFasting glucose HbA1c Lipid profile (total cholesterol, LDL, HDL, triglycerides) Creatinine Estimated glomerular filtration rate (eGFR) Ability to provide informed consent\n\nExclusion Criteria Presence of severe physical or mental disability Hospitalization due to acute illness within the past 3 months Pregnancy","30 Years","79 Years",{"count":422,"type":22},400,"This cross-sectional study aims to determine the prevalence of Cardiovascular-Kidney-Metabolic (CKM) syndrome in a community-based adult population in Gaziantep, Türkiye. In addition to estimating the prevalence across CKM stages, the study investigates the associations between CKM syndrome and two key risk indicators: the SCORE-2 cardiovascular risk score and Body Roundness Index (BRI). Findings from this study will provide valuable insights into early cardiometabolic risk profiling and support the development of regionally tailored prevention strategies.",[278,425,28],"Cardiovascular Diseases","NOT_YET_RECRUITING","2025-04-17",{"date":429,"type":41},"2025-04-25",{"date":431,"type":22},"2025-06-01",{"date":433,"type":22},"2025-12-31",{"name":435,"class":48},"University of Gaziantep",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":103},"100587078","phase-2-beneficial-effect-of-amiloride-on-progression-of-chronic-kidney-disease-100587078","NCT06923709","Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease","A-CKD","Inclusion criteria\n\nParticipants are eligible to be included in the study, only if all the following criteria apply:\n\n1. Participant must be 18 years of age including at the time of signing the informed consent.\n2. A clinical diagnosis of chronic kidney disease and:\n\n   1. eGFR ≥ 25 mL\u002Fmin\u002F1.73m2 and \\\u003C 60mL\u002F min\u002F1.73m2 at screening\n   2. UACR of ≥ 300mg\u002Fg at screening\n3. Participants must be on stable antihypertensive treatment 2 weeks before start of study drug and throughout study duration.\n4. Office blood pressure at screening meeting (visit 1), \\> 110\u002F60mmHg and \\\u003C 150\u002F90mmHg. If BP \\> 150\u002F90mmHg at visit 1, screening phase can be prolonged to 4 weeks#.\n5. Capable of giving signed informed consent.\n6. Women with childbearing potential\\* can only be included if a pregnancy test is negative at the screening visit. Moreover, women should be using contraception during the study.\n\n   * If the office blood pressure varies by approximately ±10 mmHg and is deemed acceptable by the investigator, the participant can be included.\n\n     * Women are considered of childbearing potential following menarche and until becoming post-menopausal (12 consecutive months without a menstrual period) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy (According to the Clinical Trial Facilitation Group, 2014-09-15).\n\nExclusion criteria\n\nParticipants are excluded from the study is any of the following criteria apply:\n\n1. Treatment with amiloride alone or in combination or use of other types of K-sparing diuretics, MR antagonists (Spironolactone, eplerenone, finerenone)\n2. Ongoing cancer treatment\n3. Treatment with immunosuppressive therapy within 6 months prior to screening\n4. History of organ transplantation\n5. Evidence of current infection (CRP\\> 50 and temperature \\> 38◦C)\n6. History of unstable or rapidly progressing renal disease (eGFR decreasing \\> 5ml\u002Fmin\u002F1.73m2 the last 2 months)\n7. Severe hepatic insufficiency classified as Child-Pugh C\n8. Patients on hypertension treatment who is not on stable antihypertensive treatment 2 weeks before start of study drug.\n9. Pregnancy or breastfeeding participants\n10. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.\n11. Recent cardiovascular events in a patient:\n\n    1. Less than two months post coronary artery revascularization.\n    2. Acute stroke or TIA within two months prior to screening\n    3. Acute coronary syndrome within two months prior to screening\n12. Patients who, in the judgement of the investigator may be at risk for dehydration.\n13. Known hypersensitivity to the study treatment (active substance or excipients)\n14. Known hypersensitivity to resonium\n15. Addison´s disease\n16. Gastric bypass operation\n17. Participation in other interventional trials\n18. Lactose intolerance\n19. Plasma potassium \\>4.9 mmol\u002Fl at screening",{"count":137,"type":22},[445],"PHASE2","This is a randomized, placebo-controlled, double-blinded crossover trial testing the effects of amiloride in patients with chronic kidney disease (CKD) and proteinuria.\n\nIn CKD with proteinuria, there is aberrant filtration of serine proteases and complement precursors into the tubular lumen. The interaction of these factors leads to proinflammatory complement activation, which may promote inflammation, opsonization, and formation of the membrane-attack complex, causing cell injury.\n\nWith the aim of preserving kidney function, reducing cardiovascular morbidity, and delaying renal replacement therapy in CKD, this study tests whether amiloride (10 mg\u002Fday) protects the filtration barrier, lowers albuminuria, and mitigates kidney inflammation through urokinase inhibition, independent of blood pressure effects.\n\nParticipants are randomized to receive amiloride (10 mg\u002Fday) or placebo for one week, with a 2-3-week washout period in between. Blood and urine samples are collected before and after each treatment period. Additionally, ECG, body composition measurements, blood pressure, and body weight are monitored.\n\nThe primary outcome measures are urinary C3a, soluble C5-9 (sTCC\u002FMAC), and kidney injury biomarkers KIM-1 and NGAL. Secondary endpoints include the urinary albumin\u002Fcreatinine ratio, protein\u002Fcreatinine ratio, and blood pressure.",[28,448],"Proteinuria","2025-04-10",{"date":451,"type":41},"2025-04-11",{"date":453,"type":41},"2024-10-10",{"date":455,"type":22},"2025-11-01",{"name":457,"class":48},"Odense University Hospital",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":470,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":103},"100587719","plado-for-conservative-management-of-ckd-100587719","NCT06932042","PLADO for Conservative Management of CKD","Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 years and above, having controlled glycemic and blood pressure parameters on treatment, with an established diagnosis of stages 3-5 CKD and an estimated GFR ≤59 ml\u002Fmin\u002F1.73 m2 stable for at least three months, and with a normal nutritional status as defined by the GLIM criteria, attending the CKD outpatient clinics at LAUMC-RH, willing to undergo the baseline screening and attend the monthly face-to-face visits at the outpatient department at LAUMC-RH.\n\nExclusion Criteria:\n\n* Patients with overt infection, persistent anorexia, vomiting, or diarrhea within the last month, presence of wasting diseases such as cancer, tuberculosis, liver failure, heart failure, and those with serum potassium \\>5.5 mEq\u002FL during the past 6 months.",{"count":374,"type":22},[25],"The goal of this clinical trial is to learn if a plant-dominant low protein diet, referred to as PLADO diet, works to decrease metabolic acidosis, a major risk factor for chronic kidney disease (CKD) progression, in adults with CKD. It will also learn about the safety, viability, and economic attractiveness of this diet.\n\nThe main questions it aims to answer are:\n\n* Is the PLADO diet more effective in managing metabolic acidosis in comparison with the standard-of-care CKD diet in adults with CKD?\n* Is the PLADO diet safe, viable, and economically attractive adults with CKD?\n\nResearchers will compare the PLADO diet to the standard-of-care CKD diet to see if the PLADO diet works better to decrease metabolic acidosis.\n\nParticipants will:\n\n* Receive nutrition education of the PLADO diet or the standard-of-care CKD diet via monthly sessions for 6 months.\n* Visit the clinic monthly for 6 months, then after 3 months for checkups and tests.",[28,469],"Metabolic Acidosis",[36,471,472,473,474],"metabolic acidosis","PLADO","Plant-dominant low protein diet","Nutrition education","2025-04-09",{"date":427,"type":41},{"date":478,"type":41},"2024-05-28",{"date":480,"type":22},"2026-06-30",{"name":482,"class":48},"Lebanese American University",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":103},"100585072","phase-2-impact-of-dapagliflozin-in-anemic-chronic-kidney-disease-patients-100585072","NCT06897605","Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients","Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease","Inclusion criteria\n\n1. Adults aged ≥ 18 years with CKD stage III or IV.\n2. Patients with anemia of CKD and a hemoglobin level \\\u003C 11.5 g\u002FdL\n3. Patients are receiving erythropoiesis-stimulating agent therapy.\n\nExclusion criteria\n\n1. Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.\n2. Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.\n3. Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.\n4. Patients with current malignancies or a history of malignancy within the past 2 years.\n5. Diagnosed with pure red cell aplasia.\n6. Patients with severe gastrointestinal bleeding.\n7. Pregnant or lactating females.",{"count":491,"type":22},80,[445],"Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease.",[28,495],"Anemia, Kidney Disease, Chronic","2025-03-27",{"date":498,"type":41},"2025-04-02",{"date":500,"type":22},"2025-04-01",{"date":502,"type":22},"2025-10",{"name":504,"class":48},"Mansoura University",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":32,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":512,"maxAge":275,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":103},"100583661","effect-of-oral-health-educational-program-on-the-oral-health-related-quality-of-life-in-a-group-of-children-with-chronic-kidney-disease-100583661","NCT06879223","Effect of Oral Health Educational Program on the Oral Health Related Quality of Life in a Group of Children with Chronic Kidney Disease","Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life in a Group of Children with Chronic Kidney Disease: a Before and After Pilot Study","Inclusion Criteria:\n\n* Age 8-10 years old.\n* Diagnosed with Chronic Kidney Disease\n\nExclusion Criteria:\n\n* Children with other systemic diseases.\n* Parents that refuse the participation of their children.","8 Years",{"count":514,"type":22},30,[25],"Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. This study is designed to address this gap by exploring how an oral health educational program could improve the oral health-related quality of life (OHRQoL) in this group.",[28],[519,520],"CKD OHRQL","OHEP","2025-03-14",{"date":523,"type":41},"2025-03-17",{"date":525,"type":22},"2025-06-15",{"date":259,"type":22},{"name":528,"class":48},"Cairo University",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":537,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":546,"leadSponsor":548,"locationsCount":4},"100581875","transcutaneous-laser-therapy-in-chronic-kidney-disease-100581875","NCT06855992","Transcutaneous Laser Therapy in Chronic Kidney Disease","The Effects of Transcutaneous Laser Therapy in Chronic Kidney Disease","Laser_CKD","Inclusion Criteria:\n\n* Individuals aged \\>20 years diagnosed with chronic kidney disease (CKD) stages 2-5.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 90 ml\u002Fmin\u002F1.73m² (lasting for more than three months).\n* Willing to provide routine blood test results before, during, and after each phase of the study.\n\nExclusion Criteria:\n\n* Acute kidney changes within the past three months (e.g., \\>30% decline in eGFR), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions.\n* Blood pressure exceeding 160 mmHg at the time of participation.\n* Severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer.\n* Use of photosensitizing medications, pregnancy, or malignant tumors.\n* Sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones.\n* Individuals with a hierarchical relationship to the study's principal investigator or team members (e.g., those from the same laboratory or having a student-mentor relationship).","20 Years",{"count":160,"type":22},[25],"Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. Early intervention in CKD, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis.\n\nTranscutaneous venous laser therapy is a non-invasive treatment. Current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. Additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function.\n\nThis project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. It also seeks to reduce patients' medical expenses and National Health Insurance costs.",[28],[351],{"date":544,"type":41},"2025-03-18",{"date":523,"type":22},{"date":547,"type":22},"2026-01-31",{"name":549,"class":48},"National Cheng-Kung University Hospital",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":4},"100582603","predictors-of-survival-of-dkd-patients-in-assiut-university-hospital-100582603","NCT06865456","Predictors of Survival of DKD Patients in Assiut University Hospital","Inclusion Criteria:\n\n* ● Patients age \\> 18 years old\n\n  * Both sex\n  * diabetic patients with HbA1c level \\>6.5( Type 1 and 2)\n  * Diabetic patients with CKD 4, 5 )\n  * HD Pt\n\nExclusion Criteria:\n\n* ● Chronic kidney diseases stage 1,2, and 3.\n\n  * Acute kidney injury.\n  * Patients with any other causes of CKD autoimmune disease",{"count":557,"type":22},129,"In recent years, the global prevalence of diabetes has risen significantly. According to the 9th edition of the International Diabetes Federation Atlas, an estimated 463 million adults were living with diabetes in 2019, representing approximately 9.3% of the population, with an average annual increase of 51%.\n\nDiabetes is associated with multiple complications that can significantly impact patient outcomes . In 2019 alone, around 4.2 million deaths were attributed to diabetes and its complications, accounting for approximately 11.3% of all global deaths .\n\nIn diabetic patients, several factors influence renal survival, including glycemic control, blood pressure management, lifestyle interventions, and pharmacological therapies such as renin-angiotensin-aldosterone system (RAAS) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists(9). Early detection of kidney dysfunction through biomarkers like estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR) plays a pivotal role in improving renal outcomes.\n\nThis study aims to evaluate the factors affecting Patients survival in diabetic patients, identify early predictors of renal function decline, and assess the effectiveness of current therapeutic strategies.",[28],[561],"diabetic nephropathy","2025-03-04",{"date":564,"type":41},"2025-03-07",{"date":566,"type":22},"2025-05-01",{"date":568,"type":22},"2026-09-01",{"name":570,"class":48},"Assiut University",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":580,"conditions":581,"keywords":584,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":103},"100578151","acceptability-and-feasibility-of-interventions-for-integrated-care-of-chronic-kidney-disease-with-other-long-term-health-conditions-in-malawi-a-qualitative-study-100578151","NCT06807567","Acceptability and Feasibility of Interventions for Integrated Care of Chronic Kidney Disease With Other Long-term Health Conditions in Malawi: a Qualitative Study","Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi to Inform Interventions for Earlier Detection ad Prevention (Impso Study)","Impso","Inclusion Criteria:\n\n* Eligibility criteria for each of the participant groups described above are as follows:\n\nPatients:\n\n1. Adults aged ≥ 18 years\n2. Diagnosed with CKD, or at risk of CKD, AND at least one other long-term health condition out of:\n\n   * Hypertension\n   * Diabetes mellitus\n   * HIV infection\n   * Heart failure\n   * Stroke (See Table 1 for diagnostic inclusion criteria for each of the above conditions)\n3. Receiving outpatient care at one of the selected study sites, for at least 6 months\n\nCaregivers:\n\n1. Adults aged ≥ 18 years\n2. Identified by a patient meeting the above inclusion criteria to be their primary caregiver\n\nHealthcare workers:\n\n* Adults aged ≥ 18 years\n* Currently employed as a healthcare worker at either QECH, Chiradzulu District Hospital, Ndunde Health Centre or Namadzi Health Centre.\n* Working in an outpatient clinic environments where care is delivered for patients with any of the above conditions, which may include (but is not limited to) the following:\n\n  * CKD clinic (QECH)\n  * Hypertension clinic (QECH)\n  * Diabetes clinic (QECH)\n  * HIV clinic (all study locations, including the Lighthouse clinic at QECH)\n  * Cardiology \u002Fchest clinic (QECH)\n  * General non-communicable disease (Chiradzulu District Hospital and its referring primary health centres)\n\nPolicy makers\n\n* Adults aged ≥ 18 years\n* Identified through stakeholder mapping and\u002For snowball sampling to have a leading role relevant to planning, managing and implementing services and\u002For policies for NCDs and\u002For other LTCs.\n\nExclusion Criteria:\n\n* • Under 18 years of age\n\n  * Acute physical or mental illness, which requires urgent treatment and might impact on ability to participate in and complete interview\n  * Current hospital inpatient\n  * Unable to participate in interview due to severe communication difficulties (e.g. aphasia), confusion or behavioural disturbance\n  * Declines consent",{"count":398,"type":22},"The burden of chronic kidney disease (CKD) is rising globally, but disproportionately impacting on low- and middle-income countries (LMIC) including Malawi, which have the fewest resources to manage it. Furthermore, CKD is the leading cause of catastrophic health expenditure worldwide, largely due to the extremely high costs of kidney replacement therapy (KRT) for people with kidney failure. Access to KRT remains limited in many settings, including Malawi, where there is only one nephrologist for a population of over 21 million. It is therefore essential to diagnose and treat CKD in its early stages, to facilitate earlier and more cost-effective treatment to prevent its progression to advanced disease which is associated with increased risks of kidney failure and of cardiovascular morbidity and mortality. CKD is usually asymptomatic in its early stages, so early diagnosis and treatments requires access to key diagnostic tests, in addition to strategies for channelling resources to those at the highest risk.\n\nThe causes of CKD are diverse, particularly in LMIC settings where the increasing prevalence of non-communicable diseases intersects with ongoing high burdens of infectious diseases, malnutrition, and many other social and environmental determinants of kidney health. The World Health Organization recommends integrated approaches to improve equity of quality care for people living with long-term conditions, and CKD would be amenable to integrated approaches, however CKD has been neglected from global NCD agendas and there is little data to guide the most effective methods for integrating its care with other long-term conditions (such as hypertension, diabetes and HIV infection), particularly in low-income settings such as Malawi.\n\nThe aim of this study is to explore current experiences of care for CKD and related long-term conditions, and to qualitatively evaluate the acceptability and feasibility of different potential approaches to integrating their care, amongst different stakeholders groups in Malawi.",[28,582,583],"Multimorbidity","Long-term Health Conditions",[585,351,586,587,588],"integrated care","long-term conditions","qualitative research","Malawi","2025-01-29",{"date":591,"type":41},"2025-02-04",{"date":593,"type":22},"2025-02-17",{"date":595,"type":22},"2026-03-05",{"name":597,"class":48},"Liverpool School of Tropical Medicine",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":74,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":607,"conditions":608,"keywords":610,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":617,"leadSponsor":619,"locationsCount":103},"100577151","genomic-first-testing-in-chronic-kidney-disease-100577151","NCT06794567","Genomic First Testing in Chronic Kidney Disease","Improving Diagnosis for Genetic Kidney Disease Through Early Genomic Assessment","Patients:\n\nInclusion Criteria:\n\n1. A diagnosis of CKD warranting a referral to a nephrologist for further assessment AND\n2. Screen positive for potential genetic kidney disease using the Ontario Health Provincial Genetics Program Eligibility Criteria for genetic assessment in CKD AND\n3. Index participant or substitute decision maker (SDM) can provide informed consent to participate.\n\nExclusion Criteria:\n\n1. Participant or SDM is unable to provide consent, for any reason, to be an unsuitable candidate for the study.\n2. Fail screening as set out by the Provincial Genetics Program Eligibility Criteria for genetic assessment in CKD.\n\nFamily Members:\n\nInclusion Criteria:\n\n1. Family\u002Fcaregiver or SDM can provide informed consent to participate AND\n2. Related patient participant must be enrolled in the study.\n\nExclusion Criteria:\n\n1. Family\u002Fcaregiver or SDM is unable to provide consent, for any reason, to be an unsuitable candidate for the study.\n2. Related patient participant is not enrolled in the study.\n\nHealthcare Provider:\n\nInclusion Criteria 1. Provided a referral for at least one study participant.\n\nExclusion Criteria:\n\n1\\. Is not a referring healthcare provider.\n\nQualitative Sub-Study:\n\nInclusion Criteria:\n\n1. Patient participant who is enrolled in the main study.\n2. 18 years or older.\n3. The guardian for a minor\n\nExclusion Criteria:\n\n1. \\\u003C18 years of age unless the guardian can conduct the interview\n2. Patient participant who is not enrolled in the main study.",{"count":606,"type":22},2400,"This multi-center study examines the role of genetic testing in patients with chronic kidney disease (CKD) who are identified as being at risk for genetic kidney disease, based on Ontario Health's Provincial Genetic Program (OH-PGP) guidelines. Participants will be assigned to either genome-wide sequencing or standard genetic testing, depending on when they were initially diagnosed with kidney disease.\n\nTo evaluate the impact of genetic testing, patients and caregivers will complete quality-of-life questionnaires before and after testing. Participants may also choose to take part in a one-on-one interview at the end of the study to provide additional insights. They will have the option to link their data to the Institute for Clinical Evaluative Sciences (ICES), allowing researchers to explore health outcomes such as the costs of genetic testing and healthcare resource use.\n\nFamily members of participants will be invited to provide DNA samples to help identify genetic changes in the affected individual. Referring physicians will complete a survey to assess the clinical value of genetic testing for each patient they refer. We will perform an economic analysis comparing the genome wide sequencing to the standard genetic testing group.\n\nThe study's findings will offer important guidance on how genetic testing influences patient care, clinical outcomes, and the timing of genomic assessments in managing CKD.",[28,609],"Genetic Kidney Disease",[218,611,612],"Genetic Testing","Genome wide sequencing","2025-01-21",{"date":615,"type":41},"2025-01-27",{"date":406,"type":22},{"date":618,"type":22},"2028-12-31",{"name":620,"class":48},"Dervla Connaughton",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":74,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":103},"100577153","phase-2-effect-camostat-for-kidney-protection-in-chronic-kidney-disease-100577153","NCT06794593","Effect Camostat for Kidney Protection in Chronic Kidney Disease","CamKid","Patients:\n\nInclusion criteria:\n\n1. Age ≥ 18 years.\n2. A clinical diagnosis of CKD of any course and meet the following criteria at screening:\n\n   1. eGFR ≥ 30 ml\u002Fmin\u002F1.73m2\n   2. U-ACR ≥ 300 mg\u002Fg.\n3. Stable antihypertensive treatment 2 weeks before start of investigated medical drug (IMP) and maintain this treatment throughout the study.\n4. Office blood pressure at the screening session should be \\>120\u002F70 mmHg and \\\u003C150\u002F90 mmHg.\n5. Capable of providing a signed informed consent and comply with study requirements.\n6. Women with childbearing potential must have a negative pregnancy test (urine hCG) at spot urine at the screening visit and should use contraception during the study and until one week after completion of study treatment.\n\nExclusion criteria:\n\n1. Treatment with Amiloride, Spironolactone, Aldosterone, or analogues.\n2. Treatment with NSAIDs.\n3. Hyperkalemia \\> 5.0 mmol\u002FL at screening.\n4. P-bilirubin \\> 25 umol\u002FL at screening.\n5. Ongoing cancer treatment.\n6. Treatment with immunosuppressive therapy within 6 months prior to screening.\n7. History of organ transplantation.\n8. Evidence of current infection (CRP\\>50 or temperature \\> 38 C°).\n9. Severe hepatic insufficiency classified as Child-Pugh C.\n10. Breastfeeding.\n11. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.\n12. Recent cardiovascular events \\\u003C 2 months prior to screening:\n\n    1. Coronary artery revascularization.\n    2. Acute stroke or TIA.\n    3. Acute coronary syndrome.\n13. Allergy or hypersensitivity to the IMP.\n14. Addison's disease.\n15. Gastric bypass operation.\n16. Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP.\n17. Participation in other clinical trials within the last 30 days.\n\nHealthy controls:\n\nInclusion criteria:\n\n1. Age ≥ 18 years.\n2. Good general health with no significant medical conditions or chronic illness (e.g., diabetes, hypertension, cardiovascular disease, autoimmune diseases, and cancer).\n3. Normal kidney function and no proteinuria at screening:\n\n   1. eGFR \\> 90 ml\u002Fmin\u002F1.73m2\n   2. U-ACR \\\u003C 30 mg\u002Fg\n4. Office blood pressure at the screening \\\u003C 140\u002F90 mmHg.\n5. Capable of providing a signed informed consent and comply with study requirements.\n\n7\\. Women with childbearing potential\\* must have a negative pregnancy test (urine hCG) at spot urine at the screening visit and should use contraception during the study and until one week after completion of study treatment.\n\nExclusion criteria:\n\n1. Treatment with any prescription medication except oral contraceptives.\n2. Use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)\n3. Hyperkalemia \\> 5.0 mmol\u002FL at screening.\n4. P-bilirubin \\> 25 umol\u002FL at screening.\n5. Evidence of current infection (CRP\\>50 or temperature \\> 38 C°).\n6. Breastfeeding.\n7. History of substance abuse including alcohol.\n8. Allergy or hypersensitivity to the IMP.\n9. Gastric bypass operation.\n10. Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP.\n11. Participation in other clinical trials within the last 30 days",{"count":137,"type":22},[445],"This clinical trial aims to evaluate the effects of Camostat Mesylate, a serine protease inhibitor, in patients with chronic kidney disease (CKD) and proteinuria. Proteinuria accelerates CKD progression and increases cardiovascular risks. By inhibiting serine protease activity and tubular complement activation, camostat may mitigate progressive kidney injury, potentially improving clinical outcomes.\n\nThis is an interventional, non-randomized, open-label pharmacodynamic trial that includes CKD patients with proteinuria and healthy controls. This approach has been chosen as the trial serves as a pilot study, aiming to investigate a novel treatment target in CKD patients. Including healthy controls allows a comparison of the effect of Camostat Mesilate on normal physiology versus CKD with proteinuria.\n\nParticipants will:\n\n* Follow a standardized sodium diet of 150 mmol\u002Fday for 8 days.\n* Receive oral Camostat Mesilate (200 mg thrice daily) for four days (day 5-8 on the diet).\n* Provide blood and urine samples, record blood pressure, and undergo body composition measurements at baseline, during intervention, and at study completion.\n\nThe primary effect parameters are urine sodium and water excretion, body water content\u002Fweight, and home blood pressure. Secondary endpoints are tubular complement activation, urine protease activity, ENaC activation, 24-hour urine albumin excretion, and plasma concentrations of renin, angiotensin II, aldosterone, and NT-proBNP.",[28],[32,218,448,633,634,635,636,637,250,638],"Camostat Mesylate","Serine Protease Inhibitor","Complement","ENaC","Epithelial Sodium Channel","Proteaseuria",{"date":615,"type":41},{"date":641,"type":41},"2024-11-21",{"date":643,"type":22},"2027-02-28",{"name":457,"class":48},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":23,"phases":655,"briefSummary":656,"conditions":657,"keywords":659,"overallStatus":426,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":666,"locationsCount":4},"100576098","protecting-renal-function-in-chronic-kidney-disease-patients-with-isolated-nighttime-hypertension-100576098","NCT06780865","Protecting Renal Function in Chronic Kidney Disease Patients with Isolated Nighttime Hypertension","Protection of Renal Function by Antihypertensive Treatment in Patients with Chronic Kidney Disease and Isolated Nighttime Hypertension","PRECISE","Inclusion Criteria:\n\n* Participants must be 18 years of age or older. All genders are eligible;\n* Confirmed diagnosis of Chronic Kidney Disease (CKD) according to KDIGO. guidelines;\n* UACR \\\u003C 30 mg\u002Fg (3.4 mg\u002Fmmol) and eGFR between 20-44 mL\u002Fmin\u002F1.73 m²; or UACR between 30-300 mg\u002Fg (3.4-33.9 mg\u002Fmmol) and eGFR between 20-59 mL\u002Fmin\u002F1.73 m²; or UACR between 300-5000 mg\u002Fg (33.9-565 mg\u002Fmmol) and eGFR \\> 20 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation).\n* Office blood pressure measurements below 140\u002F90 mmHg at both screening visits;\n* Daytime ambulatory blood pressure \\\u003C 135\u002F85 mmHg and nighttime systolic blood pressure ≥ 120 mmHg or diastolic blood pressure ≥ 70 mmHg;\n* No use of corticosteroids, immunosuppressants, or biologic agents for at least one month prior to enrollment;\n\nExclusion Criteria:\n\n* Presence of acute kidney injury or acute renal failure;\n* History of kidney transplantation;\n* Presence of severe arrhythmias, including severe atrial fibrillation, atrioventricular (AV) block, sinoatrial (SA) block, sinus bradycardia, malignant AV node reentrant tachycardia syndrome;\n* Secondary hypertension related to suspected or confirmed renal artery stenosis or adrenal gland disorders;\n* Poor glycemic control (HbA1c \\> 12%);\n* Orthostatic hypotension (a decrease in blood pressure of \\>20\u002F10 mmHg within 3 minutes of standing from a sitting position);\n* Women who are pregnant or breastfeeding at the time of enrollment, or not employing contraception of reproductive age;\n* NYHA (New York Heart Association) Class III-IV congestive heart failure at the time of enrollment;\n* History of myocardial infarction, unstable angina, acute heart failure, stroke, transient ischemic attack (TIA), or cerebral hemorrhage within the 12 weeks prior to enrollment;\n* Underwent coronary revascularization (Percutaneous Coronary Intervention \\[PCI\\] or Coronary Artery Bypass Grafting \\[CABG\\]), or valve repair\u002Freplacement within the 12 weeks prior to enrollment, or planned to undergo any of the aforementioned surgical procedures after randomization;\n* Any other serious diseases outside the renal and cardiovascular domains, including but not limited to malignancies, with an expected survival of less than 2 years based on the investigator's clinical judgment;\n* Presence of active malignancy requiring pharmacological treatment;\n* AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) levels \\>3 times the upper limit of normal (ULN);\n* Total bilirubin \\>2 times ULN. Patients with Gilbert's syndrome who exhibit isolated bilirubin elevation do not need to be excluded;",{"count":654,"type":22},200,[25],"Hypertension guidelines recommend the application of ambulatory blood pressure monitoring in the diagnosis and treatment of patients with hypertension. Subtypes of hypertension such as nocturnal hypertension can be found through ambulatory blood pressure monitoring. Previous studies have reported that the prevalence of nocturnal hypertension, even isolated nocturnal hypertension, is higher in patients with chronic kidney disease, and it is associated with adverse events such as cardiovascular events and progression of renal dysfunction. However, the benefit of controlling nocturnal hypertension in patients with chronic kidney disease is unclear. In this study, a total of 200 patients with chronic kidney disease and isolated nocturnal hypertension will be enrolled. Patients will be randomly divided into two treatment groups: the active antihypertensive treatment group and the placebo treatment group (1:1). The antihypertensive treatment group will be treated with arotinolol or amlodipine and clonidine to control nocturnal blood pressure, while the control group will be treated with the corresponding placebos. Randomized patients will be followed up for 2 years to evaluate the effect of controlling isolated nocturnal hypertension on the progression of chronic kidney disease in terms of EPI-estimated glomerular filtration rate (eGFR) decline and change in proteinuria.",[28,658],"Nocturnal Hypertension",[351,660],"isolated nocturnal hypertension","2025-01-15",{"date":359,"type":41},{"date":664,"type":22},"2025-01-30",{"date":618,"type":22},{"name":667,"class":48},"Shanghai Institute of Hypertension"]