[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-kidney-disease":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,55,77,105,139,163,194,221,245,274,297,320,352,373,401,433,456,484,506,529,549,576,601,621,647],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100629334","phase-1-evaluation-of-mtx-439-in-healthy-adults-and-adults-with-diabetic-kidney-disease-100629334",false,"NCT07473323","Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease","A Phase 1 Randomized, Double-blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. All genders, ages 18 to 65 years, inclusive.\n2. Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent.\n3. Willing and able to complete all protocol-required study visits and procedures.\n4. Consumption of no more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, nicotine pouches, and e-cigarettes) per week and agreement to abstain from all such products during inpatient stays.\n5. Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit.\n6. Agrees to not donate eggs (if applicable) from the time of the first infusion until 65 days after the final dose, or 125 days after the final dose for sperm (if applicable); additionally agrees to not donate blood from 56 days prior to the time of first infusion until 90 days after the last study visit or platelets\u002Fplasma from 14 days prior to the time of first infusion until 90 days after the last study visit.\n7. Participants are required to follow specific contraception measures as follows:\n\n   * Participants assigned male at birth must use a condom (even if vasectomised) at the time of Screening and for 125 days after the final dose.\n   * Participants assigned female at birth must be of nonchildbearing potential (defined as either at least 6 months surgically sterilised or at least 1 year postmenopausal and confirmed by follicle-stimulating hormone \\[FSH\\] level \\> 40 U\u002FL) OR, if of childbearing potential (defined as not sterilised via bilateral oophorectomy or hysterectomy; still menstruating; or \\\u003C 1 year has passed since the last menses, if menopausal), must use a combination of 1 highly effective method of contraception and 1 effective method of contraception. This contraceptive practice should begin at least 28 days before the first dose of study drug, continue during the study, and persist for 65 days after the final dose of study drug, if applicable.\n   * Male participants agree to ensure that their female partners who are of childbearing potential will use a highly effective method of contraception..\n8. Vital signs within the following ranges:\n\n   * Systolic blood pressure: 90-140 mmHg\n   * Diastolic blood pressure: \\\u003C 90 mmHg\n   * Pulse rate: 55-100 bpm\n   * Respiration rate: 10-16 respirations per minute\n\n   DKD participants:\n9. All of the above.\n\n   * Well-controlled diabetes requiring minimal dose adjustments of antidiabetic medications in the past 3 months and no adjustments within 30 days of Screening.\n   * Haemoglobin A1C \\\u003C 9.5%.\n   * Estimated glomerular filtration rate (eGFR) between 30 and 60.\n\nExclusion Criteria:\n\n1. Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).\n2. Body mass index (BMI) \\> 32 kg\u002Fm2 for healthy participants; \\> 40 kg\u002Fm2 for DKD participants.\n3. Use of any systemic immunosuppressant medications, medications to treat diabetes (except DKD participants), antipsychotics, anticoagulants, or other prescription medications other than contraceptives within 90 days of Screening that, as determined by the Investigator, could confound their participation in the study.\n4. Received a vaccine within 30 days of Screening.\n5. Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening except for adequately treated non-melanoma cancers of the skin and cervical carcinoma in situ.\n6. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen (HbsAg) test at Screening or a positive HIV test at Screening. For hepatitis C, a positive hepatitis C antibody (antiHCV) test is exclusionary unless the participant has previously been treated for hepatitis C, in which case they would be eligible with a negative HCV ribonucleic (RNA) test.\n7. Currently pregnant, lactating, or planning to conceive or contribute to pregnancy during the trial and up to 65 days (for participants of childbearing potential) or 125 days (for males) after the participant's last dose of study drug, if applicable.\n8. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening.\n9. History of anaphylaxis or other significant allergies in the opinion of the Investigator.\n10. History of substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year of Screening.\n11. Positive screen for drugs of abuse or alcohol at Screening or admission to the CRU (Day -1).\n12. Donation of blood within 28 days of Screening.\n13. Any clinically significant disease or laboratory abnormality detected at Screening, including diabetes mellitus, that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety, including the following:\n\n    * Haemoglobin \\\u003C 115 g\u002FL (female) or \\\u003C 135 g\u002FL (male); \\> 160 g\u002FL (female) or \\> 180 g\u002FL (male)\n    * Absolute neutrophils \\\u003C 2.0 × 109\u002FL or \\> 7.5 × 109\u002FL\n    * White blood cells \\\u003C 4.0 × 109\u002FL or \\> 11.0 × 109\u002FL\n    * Platelet count \\\u003C 150 × 109\u002FL or \\> 450 × 109\u002FL\n    * Any clinically significant abnormality on any of the Screening ECGs\n    * Alanine aminotransferase or aspartate aminotransferase greater than 1.2 times the upper limit of normal.\n14. Any surgical procedure, including planned procedures within 12 weeks of Screening.\n15. Known allergy to MTX-439 or any of its excipients.\n16. Participation in another research study of an investigational agent within 30 days of Screening or 5 half-lives of the agent, whichever is longer.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},88,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)",[29,30],"Healthy Adult Participants","Diabetic Kidney Disease",[32,33,34,30,35,36,37,38,39,40,41],"MTX-439-K101","MTX-439","Healthy Volunteers","HV","DKD","Adult","Monoclonal Antibody","SMOC2","SAD","MAD","RECRUITING","2026-06-25",{"date":45,"type":46},"2026-06-29","ACTUAL",{"date":48,"type":46},"2026-05-19",{"date":50,"type":23},"2028-01",{"name":52,"class":53},"Mediar Therapeutics","INDUSTRY",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":54},"100562226","phase-2-the-evaluation-of-the-drug-r3r01-for-the-excretion-of-protein-in-the-urine-in-patients-with-diabetic-kidney-disease-100562226","NCT06600412","The Evaluation of the Drug R3R01 for the Excretion of Protein in the Urine in Patients With Diabetic Kidney Disease.","Effects of the ABCA1 Inducer R3R01 on Albuminuria Levels in Diabetic Kidney Disease","Kidney ABC","Inclusion Criteria:\n\n1. Adults (above 18 years of age) with controlled type 2 diabetes (hemoglobin A1c less than 10.5%).\n2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration.\n3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blocking treatment.\n4. Stable treatment with lipid lowering agents for at least 4 weeks.\n5. People on SGLT2-Inhibitors should be on a stable dose of the drug for at least 3 months.\n6. UACR \\>30 mg\u002Fg and \\\u003C 5000 mg\u002Fg on two consecutive measurements.\n7. eGFR \\>30 ml\u002Fmin\u002F1.73 m2 (CKD-EPIcrea formula).\n8. Abdominal obesity Women: \\> 80 cm, Men: \\> 95 cm or fasting triglyceride \\>2.0 mmol\u002Fl.\n9. Systolic blood pressure ≥110 mmHg and ≤160 mmHg.\n10. Both female patients, as well as female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study and 90 days after the last dose of study medication.\n11. Males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form through 90 days after the last dose of study drug. They must agree to immediately inform the investigator if their partner becomes pregnant during the study.\n\nExclusion Criteria:\n\n1. Polycystic kidney disease, ANCA-associated vasculitis, or lupus nephritis.\n2. Ongoing cancer treatment.\n3. Immunosuppressive therapy or immunosuppression the prior 6 months.\n4. Nephrotic syndrome.\n5. Impaired liver function (clinically significant).\n6. Pregnancy or lactation.\n7. Failure to understand patient information or to collaborate with the investigator.\n8. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception.\n9. History of hypersensitivity to study drug and\u002For any of its excipients.\n10. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.\n11. Active or planned treatment with a medication that interacts with R3R01.\n12. Any other medical condition(s) that might put the patient at risk or influence study results in the investigators opinion, or that the investigator deems unsuitable for the study including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.",{"count":64,"type":23},60,[66],"PHASE2","The goal of this clinical trial is to to investigate whether the drug R3R01 has a beneficial effect on the amount of protein excreted in the urine in adult patients (above 18 years of age) with type 2 diabetes and resulting kidney disease.\n\nThe main questions it aims to answer are:\n\n1. Does 3 months of treatment with 200mg of the drug R3R01 morning and evening have a beneficial effect on the amount of protein excreted in the urine in patients with type 2 diabetes and kidney disease?\n2. Does R3R01 have an effect on kidney function and daily blood pressure?\n\nResearchers will compare the results of 40 people who take R3R01 to 20 people who receive an inactive substance (placebo).\n\nParticipants will receive R3R01 or the placebo as an oral tablet and undergo a selection of medical examinations - such as:\n\n* blood samples\n* urine tests\n* kidney tests involving a radiolabelled marker which is injected into the bloodstream and monitored via blood samples\n* 24 hour blood pressure monitoring via a wearable device\n* urine pregnancy test (if applicable)",[30],"2026-06-24",{"date":45,"type":46},{"date":72,"type":46},"2024-10-10",{"date":74,"type":23},"2027-04-01",{"name":76,"class":53},"River 3 Renal Corp.",{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":54},"100641084","effect-of-chinese-herbal-medicine-on-renal-function-in-diabetic-kidney-disease-100641084","NCT07657351","Effect of Chinese Herbal Medicine on Renal Function in Diabetic Kidney Disease","Effects of Chinese Herbal Medicine as an Adjunctive Therapy on Renal Function in Patients With Diabetic Kidney Disease: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Patients diagnosed with type 2 diabetes mellitus and stage 3-4 chronic kidney disease (CKD), confirmed by a nephrologist and classified as ICD-10-CM codes E11.21-E11.29 combined with N18.3-N18.4, consistent with diabetic kidney disease (DKD) definitions.\n* Ability to understand the study procedures and provide written informed consent.\n* Willingness to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Acute kidney injury or major kidney-related surgery within 3 months prior to enrollment.\n* Participation in another clinical trial within 3 months that may significantly affect renal function.\n* Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.\n* Pregnancy or breastfeeding.\n* History of malignancy currently receiving chemotherapy, radiotherapy, or other systemic anticancer treatment.\n* End-stage disease as defined under palliative care regulations.\n* Known allergy to any components of the DKD-1 herbal formula, including Astragalus membranaceus, Salvia miltiorrhiza, Chinese yam, Poria cocos, Moutan cortex, Schisandra chinensis, or Smilax glabra.",{"count":85,"type":23},66,[87],"NA","This study is a randomized controlled pilot trial designed to evaluate the effects and safety of a traditional Chinese medicine formula (DKD-1) as an add-on therapy to standard treatment in patients with Diabetic Kidney Disease (DKD). Eligible participants will be randomly assigned to receive either standard care alone or standard care combined with DKD-1 for 12 weeks. Kidney function, glycemic control, proteinuria, quality of life, and traditional Chinese medicine tongue features will be assessed before and after the intervention. The study aims to provide preliminary evidence on whether DKD-1 can improve renal function, glycemic control, and quality of life in this patient population.",[30],[91,30,92,93],"Traditional Chinese Medicine","Adjunctive Therapy","Pilot Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-15",{"date":97,"type":46},"2026-06-18",{"date":99,"type":23},"2026-06-11",{"date":101,"type":23},"2026-12-31",{"name":103,"class":104},"China Medical University Hospital","OTHER",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":54},"100538462","phase-4-mechanism-of-sglt2-inhibition-in-the-kidney-100538462","NCT06291155","Mechanism of SGLT2 Inhibition in the Kidney","Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease","Inclusion Criteria:\n\n* Aged 18-80 years.\n\n  * The lower age limit was set so renal function test results would not reflect changes associated with growth.\n* Diagnosis of type 2 diabetes for ≥ 3 years.\n* Estimated GFR \\>45 and \\\u003C 90 ml\u002Fmin\u002F1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009)\n* A screening urinary albumin-to-creatinine ratio \\\u003C3000 mg\u002Fg.\n* Willingness to participate after receiving a thorough explanation of the study.\n* Participants receiving a RAAS inhibitor must have been receiving the drug at maximum tolerable dose for at least 3 months prior to the study baseline examination.\n* Participants receiving a GLP-1 receptor agonist must have been receiving the drug for at least 3 months prior to the study baseline examination.\n* Participants must meet the current clinical guidelines for prescribing SGLT2 inhibitors, to maintain FDA-approved standards\n\nExclusion Criteria:\n\n* Clinically significant disorders of the liver \\[cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg\u002Fdl), active or uncontrolled cardiovascular disease, symptomatic peripheral vascular disease, (i.e. intermittent claudication), pulmonary diseases (including uncontrolled asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels ≤30 percent in women or ≤35 percent in men.\n* Prior and ongoing treatment with SGLT2 inhibitors\n* Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg)\n* Hematuria of unknown etiology.\n\n  * Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate.\n* Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus \\[SLE\\], cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment.\n* Currently receiving a drug regimen that includes steroids, immunosuppressants, or investigational new drugs not associated with this trial.\n* Pregnancy.\n\n  * SGLT2 inhibitors are not recommended during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies.. Women of childbearing potential must have a negative pregnancy test prior to entry and every 2 months during the study and agree to using an effective form of contraception throughout the study, such as the oral contraceptive pill or an intrauterine device. Women who are planning a pregnancy in the next three years will be excluded.\n* Known hypersensitivity to canagliflozin or iodine.\n* Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted since kidney biopsies cannot be performed safely in these individuals.\n* Massive obesity with body mass index ≥45 kg\u002Fm².\n\n  * Kidney biopsies are more technically difficult with massive obesity.\n* Allergy to iodine-containing contrast material or shellfish.\n* Non-diabetic kidney disease - based on clinical history or kidney biopsy examination.\n* History of osteoporotic fracture.\n* History of lower-limb amputation irrespective of etiology\n* Conditions likely to interfere with informed consent or compliance with the protocol.\n* Known solitary kidney\n* Size of one or both kidneys on ultrasound \\\u003C 9 cm (small kidney size is concerning for renal atrophy due to underlying kidney disease) or \\> 2 cm discrepancy between left and right kidney sizes based on largest longitudinal diameter\n* Current use of UGT enzyme inducters, lithium, and digoxin\n* Blood urea nitrogen (BUN) \\> 80 gm\u002FdL\n* INR \\> 1.4 (a)\n* PTT \\> 35 seconds (a)\n* Platelet count \\\u003C 100,000 uL (a)\n* Hemoglobin (Hgb) \\\u003C 10 mg\u002FdL (a)\n* Hydronephrosis or other important renal ultrasound findings such as significant stone disease\n\n  1. Inclusion possible after this has been obtained within range","80 Years",{"count":114,"type":23},20,[116],"PHASE4","The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.\n\nParticipants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:\n\nConsent and Screening:\n\n* Laboratory tests to determine baseline health\n* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys\n\nMonth 0:\n\n* Study entry kidney MRI (day 0)\n* Study entry kidney biopsy (within 30 days of MRI)\n* Study entry visit for dispensing 100 mg\u002Fdaily Canagliflozin medication 3 month supply\n\nMonth 3:\n\n* Study visit to dispense remaining 3 months of 100 mg\u002Fdaily Canagliflozin medication\n* Review of systems\n\nMonth 6:\n\n* Follow-up kidney MRI\n* Follow-up kidney biopsy\n\nStudy participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).\n\nParticipants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples.",[119,30],"Type 2 Diabetes",[121,122,123,124,125,126,127,128,129,130],"Kidney biopsy","Kidney MRI","SGLT2 inhibitor","SGLT2i","FDA-approved","Renal biopsy","Renal MRI","Type 2 diabetes","Canagliflozin","INVOKANA","2026-06-09",{"date":99,"type":46},{"date":134,"type":46},"2024-01-01",{"date":136,"type":23},"2028-02-28",{"name":138,"class":104},"University of Michigan",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":24,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100502465","phase-2-trial-of-semaglutide-for-diabetic-kidney-disease-in-type-1-diabetes-100502465","NCT05822609","Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes","RT1D","Inclusion Criteria:\n\n* Adults (≥18 years) with type 1 diabetes\n* Diabetes duration of ≥5 years\n* Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg\u002Fg, on the most recent two measurements within the prior 3 years\n* Estimated glomerular filtration rate ≥ 20 mL\u002Fmin\u002F1.73m2\n* Stable doses of drugs altering blood pressure (e.g., Angiotensin-converting enzyme inhibitor) required for at least 4 weeks prior to randomization, and requested for the duration of the trial\n* Stable doses of lipid-lowering medications required for at least 4 weeks prior to randomization, and requested for the duration of the trial\n* Adequate contraceptive method for females of child-bearing potential\n\nExclusion Criteria:\n\n* HbA1c \\>9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe illness requiring hospitalization in past 30 days\n* Other causes of diabetes mellitus, including type 2 diabetes and maturity-onset diabetes of the young (MODY)\n* Chronic kidney disease unrelated to diabetes\n* Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or thyroid nodule palpated by endocrinologist at screening\n* Personal history of pancreatitis\n* Current\u002Fplanned pregnancy or nursing\n* Uncontrolled thyroid disease or hypertension (Systolic blood pressure \\[SBP\\] ≥ 160 mm Hg or diastolic blood pressure \\[DBP\\] ≥ 100 mm Hg despite treatment)\n* Proliferative retinopathy with treatment in the past 6 months\n* Uncontrolled or potentially unstable diabetic retinopathy or maculopathy, verified by fundus examination with pupil dilation unless performed using a digital fundus photography camera specified for non-dilated examination\n* More than 2 severe hypoglycemic episodes (requiring glucagon and\u002For assistance from another person) in the past 6 months\n* Frequent hypoglycemia during the last two weeks of the study run-in phase (time below range \\[\\\u003C70 mg\u002FdL\\] ≥4%)\n* Pramlintide and the use of glycemia treatments not approved for type 1 diabetes by the FDA, e.g., metformin, SGT-2 inhibitor, GLP-1 receptor agonist, closed loop insulin delivery using unapproved algorithms\n* Significant systemic conditions or treatment such as cancer or immunomodulators\n* Known liver disease other than non-alcoholic fatty liver disease (NAFLD) or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>100 IU\u002FL, history of severe gastrointestinal disease (e.g., gastroparesis) or gallstones\n* Body mass index \\\u003C20 kg\u002Fm2\n* Known or suspected allergy\u002Fsensitivity to semaglutide or its excipients\n* Pregnant, breast feeding, or the intention of becoming pregnant\n* The receipt of any investigational drug within 3 months prior to this trial\n* Previously randomized in this trial",{"count":64,"type":23},[66],"The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.",[30,150],"Type 1 Diabetes",[152],"Glucagon-like peptide-1 receptor agonist","2026-05-29",{"date":155,"type":46},"2026-06-02",{"date":157,"type":46},"2024-04-05",{"date":159,"type":23},"2027-12",{"name":161,"class":104},"University of Washington",4,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":24,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100633221","phase-4-spironolactone-alternate-dosing-vs-finerenone-in-elevated-potassium---k-safety-study-100633221","NCT07523867","Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study","Safety of Finerenone Versus Alternate-Day Spironolactone in Patients With Heart Failure and Diabetic Kidney Disease at High Risk for Hyperkalemia: The SAFE-K Randomized Trial","SAFE-K","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of heart failure, regardless of left ventricular ejection fraction\n* Diagnosis of type 2 diabetes mellitus\n* Diabetic kidney disease, defined by the presence of albuminuria (urinary albumin-to-creatinine ratio ≥ 30 mg\u002Fg)\n* Estimated glomerular filtration rate (eGFR) ≥ 25 mL\u002Fmin\u002F1.73 m²\n* Serum potassium between 5.0 and 5.5 mEq\u002FL at screening\n* Receiving or eligible to receive standard of care therapy for heart failure\n* Ability to provide written informed consent\n* Ability to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Serum potassium \\> 5.5 mEq\u002FL at screening\n* Acute kidney injury at the time of enrollment\n* Symptomatic hypotension or systolic blood pressure \\\u003C 90 mmHg\n* Clinically significant arrhythmias requiring immediate intervention\n* Known hypersensitivity or contraindication to finerenone or spironolactone\n* Use of potassium-sparing diuretics other than the study drugs\n* Pregnancy or breastfeeding\n* Participation in another interventional clinical trial\n* Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures",{"count":64,"type":23},[116],"This study evaluates the safety of finerenone compared with alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia.\n\nPatients with chronic kidney disease and heart failure often benefit from mineralocorticoid receptor antagonists, but their use is frequently limited by elevated potassium levels. Finerenone has been associated with a lower risk of hyperkalemia in clinical trials, but direct comparisons with spironolactone in high-risk patients are limited.\n\nIn this randomized study, eligible participants will be assigned to receive either finerenone once daily or spironolactone on alternate days, in addition to standard therapy. Patients will be closely monitored during hospitalization and followed for 4 weeks.\n\nThe primary outcome is clinically relevant hyperkalemia, defined by elevated potassium levels or the need to adjust or discontinue treatment due to hyperkalemia. Secondary outcomes include changes in potassium levels, kidney function, and clinical events.\n\nThis study aims to provide practical evidence to guide the safe use of mineralocorticoid receptor antagonists in patients at high risk for hyperkalemia.",[175,30,176],"Heart Failure","Hyperkalemia",[178,179,180,181,176,182,183],"Finerenone","Spironolactone","Heart Failure Treatment","Chronic Kidney Disease","Mineralocorticoid Receptor Antagonist","Cardiorenal Syndrome","2026-05-09",{"date":186,"type":46},"2026-05-13",{"date":188,"type":23},"2026-04",{"date":190,"type":23},"2026-11",{"name":192,"class":193},"Hospital de Messejana Dr. Carlos Alberto Studart Gomes","OTHER_GOV",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":36,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":201,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":24,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":54},"100497609","phase-2-nad-augmentation-in-diabetes-kidney-disease-100497609","NCT05759468","NAD Augmentation in Diabetes Kidney Disease","NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. A man or a postmenopausal woman (complete cessation of menses for one or more years and \u002For FSH \\> 20 U\u002FL), 30 years or older\n2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:\n\n   1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.\n   2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.\n   3. HbA1c \\>6.4%; or 2 fasting glucose \\> 125 mg\u002FdL\n3. Has an average of two or more morning UACR equal to or above 100mg\u002Fg creatinine each of which must be equal to or greater than 60 mg \u002F g creatinine with at least one UACR value measured during the screening visit.\n\n   a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.\n4. If type 2 diabetic and UACR is \\> 300 mg\u002Fg creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.\n5. eGFR \\> 25 mL\u002F min \u002F 1.73 m2\n6. Hemoglobin A1c \\\u003C10%\n7. Able to speak English or Spanish or Haitian Creole\n8. Willing and able to provide written informed consent\n9. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.\n\nExclusion criteria:\n\n1. Fasting morning UACR \\> 5,000 mg\u002F g creatinine\n2. Other laboratory abnormalities:\n\n   1. Has AST or ALT \\> 3 times the upper limit of normal\n   2. eGFR \\\u003C 25 mL\u002F min \u002F 1.73 m2\n   3. Hematocrit \\\u003C 0.34 or \\> 0.50 L\u002FL\n3. A major adverse cardiovascular event in preceding 3 months\n4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter\n5. Current alcohol or substance use disorder or dependence (DSM 5 criteria).\n6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.\n7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.\n8. Has a history of anaphylaxis from vitamin B3 derivatives\n9. BMI \\> 42.5 kg\u002F m2\n10. If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.","30 Years",{"count":203,"type":23},156,[66],"A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.",[207,30],"Type2diabetes",[209,210,211],"diabetes","type 2 diabetes","kidney disease","2026-04-08",{"date":214,"type":46},"2026-04-13",{"date":216,"type":46},"2023-04-13",{"date":218,"type":23},"2027-03-31",{"name":220,"class":104},"Brigham and Women's Hospital",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":112,"enrollmentInfo":228,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":54},"100550883","multimodal-magnetic-resonance-imaging-in-evaluation-of-diabetic-kidney-disease-100550883","NCT06452862","Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease","the Value of Multimodal Magnetic Resonance Imaging in the Diagnosis and Treatment Monitoring of Diabetic Kidney Disease","Inclusion Criteria:\n\n* Clinically diagnosed diabetic kidney disease (DKD)\n* Age 18-80 years\n\nExclusion Criteria:\n\n* Malignant tumor, active infection, or life expectancy \\\u003C1 year\n* Pregnancy or lactation\n* MRE contraindications (metal implants, claustrophobia, severe arrhythmia) or poor image quality\n* eGFR \\\u003C15 mL\u002Fmin\u002F1.73m² or receiving renal replacement therapy\n* Other primary kidney diseases or systemic diseases affecting renal function",{"count":229,"type":23},150,"OBSERVATIONAL","The goal of this study is to investigate the value of noninvasive evaluation of multimodal magnetic resonance imaging in diagnosis and treatment of diabetic kidney disease (DKD). We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD, and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators. Multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys.",[30],[30,234,235,236],"Magnetic Resonance Imaging","Magnetic Resonance Elastography","Diabetes","2026-04-06",{"date":214,"type":46},{"date":240,"type":46},"2024-06-06",{"date":242,"type":23},"2028-06-06",{"name":244,"class":104},"Shengjing Hospital",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":24,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":54},"100605967","improving-kidney-care-in-type-2-diabetes-a-study-of-pharmacist-prescribing-versus-usual-care-100605967","NCT07169422","Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care","Community Pharmacist Prescription for Diabetic Kidney Disease (Rx4DKD): A Randomized Controlled Trial and Implementation Study","RX4DKD","Inclusion Criteria:\n\n* Adults ≥18 years with T2D and DKD (eGFR≥ 30-60 ml\u002Fmin\u002F1.73m2 and\u002For UACR≥3 mg\u002Fmmol)\n* Adults who do not have primary care provider,\n* Adults who are eligible for initiation of treatment with RASi, SGLT2i or nsMRA\n\nExclusion Criteria:\n\n* Hypotension\n* Type 1 diabetes\n* History of allergy or intolerance to either, renin angiotensin system inhibitor (RASi), SGLT2 inhibitor (SGLT2i) and nonsteroidal mineralocorticoid receptor antagonist (nsMRA).\n* Already receiving all three medications: RASi, SGLT2i, and nsMRA .\n* Exceed algorithm thresholds for potassium levels or eGFR less than 30 mL\u002Fmin\u002F1.73m²\n* Limited life expectancy of less than 1 year\n* Followed by a subspecialty physician (e.g., nephrologist or endocrinologist)\n* Unable to give consent",{"count":254,"type":23},120,[87],"Type 2 diabetes is the leading cause of chronic kidney disease, which can result in serious complications such as kidney failure and heart disease. Although effective medications exist to slow the progression of kidney damage, they are often underused in primary care, particularly for individuals without a regular family doctor. In response to this gap, 46 community pharmacy-led primary care clinics were launched across Nova Scotia in 2023 to serve under-resourced areas. Pharmacists at these clinics can prescribe for many chronic conditions, but currently not for diabetic kidney disease. To address this, the research team collaborated with kidney, diabetes, and primary care experts, patient partners and regulatory bodies to develop and validate step-by-step prescribing guide (called algorithms) that support pharmacists in identifying and managing diabetic kidney disease. All medications included are approved, publicly funded in Nova Scotia, target people with earlier categories of diabetic kidney disease and includebuilt-in safety monitoring, nurse practitioner consultation or referral to a kidney doctor. This study will evaluate whether these algorithms improve kidney protective medication use which have shown to be beneficial for people with diabetes and kidney disease. The investigators will recruit 120 adults with type 2 diabetes from a provincial diabetes registry who do not have a primary care provider and screen them at pharmacy clinics for diabetic kidney disease. Those eligible and who wish to participate will be randomly assigned to either an intervention group receiving pharmacist-led care using the algorithms or a control group receiving usual care through walk-in, mobile, or virtual clinics. The investigators will measure how many patients begin and continue recommended medications, as well as any medication-related side effects or hospitalizations. Pharmacist participants will also complete a survey to identify what helps or hinders implementation in real-world practice. This research is relevant because it aims to expand access to kidney-protective treatments for people with diabetes, especially those with early forms of diabetic kidney disease who do not have regular access to primary care provider, ultimately improving long-term health outcomes.",[30,119,181],[259,260,210,261,262,263,264],"diabetic kidney disease","pharmacist-led prescribing","guideline directed medical treatments","pharmacy care models","decision support algorithym","chronic kidney disease","2026-03-16",{"date":267,"type":46},"2026-03-18",{"date":269,"type":23},"2026-03-01",{"date":271,"type":23},"2028-07-01",{"name":273,"class":104},"Nova Scotia Health Authority",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":24,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":54},"100594666","phase-2-formoterol-in-diabetes-100594666","NCT07022418","Formoterol in Diabetes","Prospective Randomized Pilot Trial of Formoterol in Patients With Diabetic Kidney Disease","Inclusion Criteria:\n\n* Adults aged 18-75\n* Diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria\n* On stable medical therapy for at least 3 months\n* Stage CKD G2 to G3b; A2-A3 as defined by eGFR with no requirement for renal biopsy for diagnosis\n* Diabetic kidney disease as per Nephrologist\n* Urinary albumin to creatinine excretion rate (UACR) 200-5000 mg\u002Fg\u002F24hrs on at least two occasions (one of these can be a spot UACR)\n* HbA1c \\\u003C8%\n* Receiving stable doses of ACE inhibitor or ARB therapy prior to screening (at least 3 months, unless contraindicated) and\u002For a stable dose of an SGLT inhibitor (at least 3 months preceding enrollment)\n* Receiving stable doses of all additional anti-HTN medications, insulin, oral and injectable non-insulin agents and cholesterol lowering medications at least 3 months prior (unless contraindicated) to randomization and agree to maintain until the study's conclusion.\n* Willing and able to comply with schedule of events and protocol requirements, including written informed consent.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant or breast feeding or who plan on becoming pregnant\n* Currently take beta-agonists\n* Organ transplant recipients\n* Any history of New York Heart Association (NYHA) class III\u002FIV heart failure or recent history of serious heart problem (CABG, stroke, MI) in the past 12 months\n* Any history of asthma\n* Patients with serum potassium levels \\\u003C3.5 mEQ\u002FL\n* Patients with uncontrolled HTN SBP \\>150mmHg, DBP \\>95mmHg\n* EKG showing QTc elongation or tachyarrhythmia; including sinus tachycardia \\>100bpm\n* Contraindications to formoterol fumarate (hypersensitivity, including patients with known hypersensitivity to ACE inhibitors or ARBs)\n* Advanced organ failure\n* Untreated\u002Funcontrolled cardiovascular, pulmonary, or gastrointestinal disease\n* Patients with BMI \\>50\n* Active untreated cancer\n* Alcohol or drug abuse in the past 6 months\n* Being involuntarily incarcerated\n* Participating in another interventional study\n* Unable or unwilling to do the 36-week intervention","75 Years",{"count":254,"type":23},[66],"The purpose of the study is to evaluate if formoterol fumarate is effective in treating patients with diabetic kidney disease. Study participants will be randomly assigned to either receive formoterol fumarate (in addition to their current standard of care treatment) or standard of care treatment only. Study participants will have a 50% chance of receiving formoterol fumarate and a 50% chance of not receiving formoterol fumarate. Both groups will continue their standard of care treatment during the study. The primary goal is to gather data on feasibility and effect sizes to properly power a future clinical trial.",[286,30],"Diabetic Nephropathies",[236],"2026-02-03",{"date":290,"type":46},"2026-02-05",{"date":292,"type":46},"2025-12-01",{"date":294,"type":23},"2027-11",{"name":296,"class":104},"Medical University of South Carolina",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":304,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100620039","gut-microbiota-and-serum-metabolites-as-predictors-of-glycemic-variability-and-outcomes-in-diabetic-kidney-disease-100620039","NCT07352436","Gut Microbiota and Serum Metabolites as Predictors of Glycemic Variability and Outcomes in Diabetic Kidney Disease","Prospective Cohort Study on the Impact of Gut Microbiota and Serum Metabolites on Glycemic Variability and Clinical Outcomes in Patients With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Age 18-65 years\n2. Diagnosis of Diabetic Kidney Disease (DKD)\n3. Type 2 Diabetes Mellitus\n4. Stable Antidiabetic Regimen:The antidiabetic regimen must have been stable for at least 3 months prior to study enrollment.\n5. Willingness to Provide Informed Consent:\n\nParticipants must voluntarily sign an informed consent form to participate in the study. -\n\nExclusion Criteria:\n\n1. Acute Diabetic Complications:\n\n   Participants with acute diabetic complications, such as diabetic ketoacidosis (DKA), or with primary kidney diseases like primary glomerulonephritis, nephrotic syndrome, or lupus nephritis.\n2. Infection or Stress Conditions:\n\n   Participants in a state of infection, trauma, or other stress conditions.\n3. Pregnancy or Lactation:\n\n   Women who are pregnant, breastfeeding, or planning to become pregnant in the next month.\n4. Severe Dermatologic Conditions:\n\n   Participants with severe dermatologic conditions, such as extensive eczema, widespread scars, tattoos, herpetic dermatitis, severe edema, or psoriasis.\n5. Skin Issues with Sensor Application:\n\n   Participants with severe skin issues at the site of sensor application, such as burns, injuries, sunburns, ulcers, or scars from prior surgery.\n6. Coagulation or Blood Disorders:\n\n   Participants with abnormal coagulation, anemia, or abnormal hematocrit.\n7. Chronic Gastrointestinal Diseases or Surgery History:\n\n   Participants with chronic gastrointestinal diseases or a history of gastrointestinal or biliary surgery.\n8. Recent Probiotic or Antibiotic Use:\n\nParticipants who have used probiotics or prebiotics, or received antibiotic treatment for more than 3 days in the past 3 months, or have consumed yogurt or yogurt-containing foods\u002Fbeverages in the past week.",{"count":305,"type":23},270,"Diabetic kidney disease (DKD) is one of the main complications of diabetes and a leading cause of end-stage kidney disease. Blood glucose variability is closely associated with disease progression in individuals with DKD. Recent evidence suggests that gut bacteria and their circulating metabolites may play important roles in regulating blood glucose variability and clinical outcomes. However, it remains unclear whether gut bacteria and blood metabolites influence DKD progression through effects on blood glucose variability.\n\nThis study aims to (1) characterize gut bacteria and blood metabolites in individuals with DKD at different stages and levels of disease severity, and evaluate their value in predicting adverse outcomes; (2) assess the relationships among gut bacteria, blood metabolites, and blood glucose variability; and (3) determine whether gut bacteria and blood metabolites affect clinical outcomes by modulating blood glucose variability.\n\nA total of 270 individuals with DKD will be enrolled in a prospective observational cohort. The investigators will conduct continuous glucose monitoring and collect stool and blood samples for advanced analyses of gut microbiota and blood metabolites. The objective is to clarify how gut bacteria and circulating metabolites relate to blood glucose variability and disease prognosis, and to develop tools to identify high-risk individuals at an early stage. Ultimately, the findings may provide new insights and strategies to improve clinical care and quality of life for individuals with DKD.",[30],[30,309,310],"Glycemic Variability","Gut Microbiota","2026-01-12",{"date":313,"type":46},"2026-01-20",{"date":315,"type":23},"2026-02-01",{"date":317,"type":23},"2029-07-30",{"name":319,"class":104},"Eighth Affiliated Hospital, Sun Yat-sen University",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":331,"conditions":332,"keywords":338,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100432824","diabetic-nephropathy-in-people-with-diabetes-prevalence-and-predictive-factors-100432824","NCT04916132","Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors","Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors","PRIMETIME2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Diagnosis with T2DM according to the American diabetes Association (20)\n* eGFR \\>30 mL\u002Fmin\u002F1.73 m2 (maximum six months old)\n* urine-albumin\u002Fcreatinine-ratio (uACR) \\> 700 mg\u002Fg or 24 hours urine albumin \\>700 mg on more than one measurement\n\nExclusion Criteria:\n\n* Signs of acute kidney failure according to the KDIGO classification (21) at the time for kidney biopsy or the last 6 months before kidney biopsy\n* Factors that increases the risk of complications due to kidney biopsy:\n\n  * Hemoglobin \\\u003C 6 mmol\u002FL\n  * INR \\>1,4 at the time for biopsy\n  * Platelet count \\\u003C 100 x 109\u002Fl\n  * Uncontrolled high blood pressure (defined as systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg)\n  * Only one functioning kidney\n  * Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy\n  * Multiple bilateral kidney cysts\n  * Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy\n  * Unwilling to receive blood transfusion\n  * Unable to lie flat in bed six hours after biopsy\n  * Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines\n* Unable to understand written and oral information\n* Kidney transplant recipient\n* Previous medical kidney biopsy\n* Women who are pregnant or planning to become pregnant before the kidney biopsy is performed\n* Treatment with Marcoumar (all other anticoagulants are accepted)\n* High thromboembolic risk combined with held in anticoagulation therapy according to the report \"Perioperative regulation of antithrombotic treatment\" (PRAB) (22)\n\n  * mechanical heart valve\n  * atrial fibrillation AND CHA2DS2-VASc\\> 5 and\u002For stroke within the last three months\n  * recurrent venous thromboembolism OR venous thromboembolism within the last three months\n  * less than 6 weeks after uncomplicated Acute Coronary Syndrome (ACS) with or without revascularization (Percutaneous Coronary Intervention (PCI)) with Bare Metal Stents (BMS) or Coronary Artery Bypass Grafting (CABG))\n  * less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES))\n  * less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis)\n  * less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG)\n  * less than 3 months after revascularization in individuals with stable CAD (PCI with DES)\n  * less than 3 months after stroke, or Transient Ischemic Attack (TIA)\n* Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy\n\nIf a participant meets one or more exclusion criteria, that are reversible, the participant can be rescreened later on, to evaluate whether or not the participant now is qualified for participation.","120 Years",{"count":330,"type":23},300,"a prospective, observational, multi-center study with a cohort of 300 patients with Type 2 diabetes and macroalbuminuria. Prospectively we will collect kidney biopsies and analyse the transciptome of the kidney tissue and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.",[333,334,30,286,335,336,337],"Chronic Kidney Diseases","Albuminuria","Diabetes type2","Molecular Sequence Variation","Kidney Biopsy",[339,340,341],"diabetic nephropaty","precision medicine","kidney biopsy","2025-12-17",{"date":344,"type":46},"2025-12-24",{"date":346,"type":46},"2021-08-10",{"date":348,"type":23},"2043-12-31",{"name":350,"class":104},"Herlev Hospital",13,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":201,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":54},"100567291","phase-1-a-study-to-evaluate-the-safety-tolerability-pk-and-pd-of-ap303-in-dkd-patients-100567291","NCT06666283","A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients","A Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Diabetic Kidney Disease Patients With Renal Impairment.","Inclusion Criteria:\n\n1. Male and female participants, ≥30 years of age at the time of signing the informed consent form.\n2. BMI (body mass index) 18-30 kg\u002Fm².\n3. Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..\n4. Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.\n5. Hemoglobin A1c ≥6.5% but ≤10.5% at the screening visit.\n6. Estimated GFR ≥30 mL\u002Fmin\u002F1.73m² but \\\u003C 60 mL\u002Fmin\u002F1.73m² at the screening visit.\n7. Urinary albumin to creatinine ratio ≥ 30 mg\u002Fg at the screening visit.\n\nExclusion Criteria:\n\n1. Chronic kidney disease other than type 2 diabetic kidney disease.\n2. Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.\n3. Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.\n4. Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.\n5. Peripheral edema above the ankle level at the screening or randomization visit.\n6. Confirmed (based on the average of 2 separate resting blood pressure measurements in a sitting position, after at least 5 minutes rest) systolic BP greater than 160 or less than 90 mmHg, and diastolic BP greater than 100 or less than 50 mmHg at screening.\n7. Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack, cardiovascular surgery within 6 months prior to the screening visit.\n8. Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG: e.g.\n\n   * QTc interval (QTcF \\> 450 ms for male and QTcF \\> 470 ms for female) based on the average interval on triplicate ECGs obtained after 5 minute's rest in a supine position\n   * Notable resting bradycardia (mean HR \\\u003C 40 bpm)\n   * Notable resting tachycardia (mean HR \\> 100 bpm)\n   * ECG with QRS and\u002For T wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves)\n   * Any other significant abnormality\n9. Implantation of cardiac pacemaker or clinically significant arrhythmia, e.g. atrial fibrillation, atrial flutter, right or left bundle branch block, Wolf-Parkinson-White Syndrome.\n10. Current or previous treatment with a thiazolidinedione (e.g., medications containing pioglitazone or rosiglitazone, like Actos, Avandia, ActoplusMet, Avandamet, Avandaryl), PPARa agonist (like fenofibrate) or any dual\u002Fmultiple PPARa\u002Fg agonist (e.g., Chiglitazar Sodium) in the 3 months preceding screening visit.\n11. Previous treatment with CYP2C8 inducer or strong\u002Fmoderate inhibitor (refer to the list in Appendix 4) in the 1 month preceding screening visit.\n12. Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs) (except prophylactic stable low dose aspirin, defined as its dose not higher than 100 mg daily; paracetamol\u002Facetaminophen was allowed) in the last month before screening.\n13. ALT or AST \\>1.5 × ULN, or laboratory tests revealed other clinically significant abnormalities in liver function at screening.\n14. Creatine phosphokinase (CPK) elevated \\> 3 x ULN at screening visit or history of drug-induced myopathy.\n15. History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).\n16. Participants who have had significant acute infection, e.g., COVID-19, influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks before study drug administration.\n17. Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb), human immunodeficiency virus (HIV Ab) or syphilis AB.\n18. Dosed with a small-molecule investigational drug within 3 months, or biologic investigational drug within 3 months or 5 half-lives (whichever is the longer) prior to first dose of this study.\n19. History of drug and\u002For alcohol abuse or addiction. History (within 3 months of screening) of alcohol consumption exceeding 3 and 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol) for male and female, respectively.\n20. Within 2 weeks prior to admission, use of \\>5 cigarettes or equivalent nicotine-containing product per day.\n21. Medical or social conditions that would potentially interfere with the participant's ability to comply with the study visit schedule or the study assessments.",{"count":360,"type":23},18,[26],"The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.",[30],"2025-09-05",{"date":366,"type":46},"2025-09-11",{"date":368,"type":46},"2025-02-27",{"date":370,"type":23},"2025-09-25",{"name":372,"class":53},"Alebund Pharmaceuticals",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":18,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":24,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":54},"100604913","phase-4-role-of-finerenone-in-african-american-veterans-with-diabetic-kidney-disease-100604913","NCT07155694","Role of Finerenone in African American Veterans With Diabetic Kidney Disease","Inclusion Criteria:\n\n1. Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random\u002F post prandial blood glucose of more than 199mg%)\n2. African American veterans\n3. Age 20-90 years\n4. eGFR ≥25-89 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation)\n5. Albuminuria of 30 mg\u002Fg or higher\n6. BMI=18-39.9\n7. Blood pressure controlled to ≤140\u002F90\n8. Ability to provide informed consent before any trial related activities are conducted.\n\nExclusion Criteria\n\n1. If a patient is on statin, need to be on a stable dose for a month.\n2. Biopsy proven diagnosis of glomerular disease\u002Fglomerulonephritis\n3. Active smokers,\n4. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)\n5. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure\n6. Hypersensitivity to empagliflozin or finerenone\n7. Patients on dialysis\n8. eGFR less than 25 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI equation\n9. Planned surgery or planned hospital admission within 5 months of participation in the study\n10. At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)\n11. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.\n12. Proven diagnosis of Polycystic Kidney Disease.","20 Years","90 Years",{"count":382,"type":23},30,[116],"Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.\n\nSecondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin\u002Fcreatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).",[30],[387,178,388,389,181,30,390],"Empagliflozin","Empagliflozin and Finerenone combination","Podocyte Injury","Diabetes Mellitus","2025-08-26",{"date":393,"type":46},"2025-09-04",{"date":395,"type":23},"2025-09",{"date":397,"type":23},"2027-08",{"name":399,"class":400},"Washington D.C. Veterans Affairs Medical Center","FED",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":408,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":411,"briefSummary":412,"conditions":413,"keywords":417,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"100444280","phase-1-manatee-t1d-metformin-and-automated-insulin-delivery-system-effects-on-renal-vascular-resistance-insulin-sensitivity-and-cardiometabolic-function-in-youth-with-type-1-diabetes-100444280","NCT05065372","MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes","MANATEE-T1D","Inclusion Criteria:\n\n* T1D and using an automated insulin delivery system or multiple daily insulin injections\u002Fmanual insulin pump plus continuous glucose monitor for \\> 6 months\n* Age 12-25 years\n* Use of an automated insulin delivery system or multiple daily insulin injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor for \\> 6 months\n* Hemoglobin A1c \\\u003C 11%\n* No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) (within 30 days)\n* Pubertal (Tanner stage ≥ 2)\n* Weight \\> 54 kg and BMI \\> 5th percentile for age and sex\n\nExclusion Criteria:\n\n* Blood pressure \\> 140\u002F90 mm Hg\n* Hemoglobin \\\u003C 9 g\u002FdL\n* Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2 or serum creatinine \\> 1.2 mg\u002FdL or history of urinary albumin to creatinine ratio ≥ 300mg\u002Fg or history of acute kidney injury\n* Use of anti-diabetic agents except insulin, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB's), diuretics, daily non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, sulfonamides, procaine, thiazosulfone or probenecid\n* Seafood or iodine allergy\n* Pregnancy or breast feeding for females","12 Years","25 Years",{"count":64,"type":23},[26],"Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Yet, type 1 diabetes is a complex disease with pathophysiology that extends beyond beta-cell injury and insulin deficiency to include insulin resistance and renal vascular resistance, factors that accelerate cardiovascular disease risk. We have shown that metformin improved peripheral insulin sensitivity and vascular stiffness in youth with type 1 diabetes on multiple daily insulin injections or standard insulin pumps. However, metformin's effect on kidney and endothelial outcomes, and the effects of type 1 diabetes technologies, with or without metformin, on any cardiovascular or kidney outcome, remains unknown. Automated insulin delivery systems combine an insulin pump, continuous glucose monitor, and control algorithm to modulate background insulin delivery and decrease peripheral insulin exposure while improving time in target range and reducing hypoglycemia. We hypothesize that automated insulin delivery systems, particularly when combined with metformin, may modulate renal vascular resistance and insulin sensitivity, thereby impacting cardiometabolic function. MANATEE-T1D is a randomized, double-blind, placebo-controlled trial of 4 months of metformin 2,000 mg daily in 40 youth aged 12-25 years with type 1 diabetes on automated insulin delivery systems vs. 20 control youth with type 1 diabetes on multiple daily injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor which will assess for changes in calculated renal vascular resistance and gold standard measures of whole-body and adipose insulin sensitivity, arterial stiffness, and endothelial function.",[150,30,414,415,416],"Cardiovascular Diseases","Endothelial Dysfunction","Insulin Sensitivity",[418,419,420,421,422],"Type 1 diabetes","Youth","Insulin sensitivity","Cardiovascular function","Diabetic kidney disease","2025-06-10",{"date":425,"type":46},"2025-06-13",{"date":427,"type":46},"2022-07-01",{"date":429,"type":23},"2027-07-31",{"name":431,"class":104},"Kalie Tommerdahl",2,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":201,"maxAge":112,"enrollmentInfo":440,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":54},"100509829","a-long-term-follow-up-study-of-participants-exposed-to-react-100509829","NCT05918523","A Long-Term Follow-Up Study of Participants Exposed to REACT","A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004","Inclusion Criteria:\n\n* The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.\n\nExclusion Criteria:\n\n* The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.",{"count":441,"type":23},80,"The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).",[30,333],[445,36,446],"REACT","CKD","2025-05-27",{"date":449,"type":46},"2025-05-28",{"date":451,"type":46},"2023-12-11",{"date":453,"type":23},"2028-03",{"name":455,"class":53},"Prokidney",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":24,"phases":466,"briefSummary":467,"conditions":468,"keywords":470,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":351},"100466148","effects-and-safety-of-diabetic-guideline-algorithm-implementation-performed-by-primary-care-physicians-in-the-community-100466148","NCT05349955","Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community","Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)","GUARD","Inclusion Criteria:\n\n* ①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;\n* ②Diagnosed type 2 diabetes (ADA criteria):\n* A. Typical symptoms of diabetes + random blood sugar ≥ 11.1mmol\u002FL;\n* B. Fasting blood glucose (FPG) ≥ 7.0mmol\u002FL (fasting blood glucose is defined as no caloric intake within 8 hours);\n* C. Oral glucose tolerance test 2h blood glucose (OGTT) ≥ 11.1mmol\u002FL (2h after meal);\n* D. have been treated with antidiabetic drugs;\n* Each blood sugar test must be repeated to confirm the diagnosis;\n* ③Complicated with chronic kidney disease and\u002For very high\u002Fhigh risk of cardiovascular disease, meet any one of the following:\n* A. ASCVD, including coronary heart disease, cerebral infarction, peripheral vascular disease;\n* B. Or target organ damage (albuminuria, renal impairment with eGFR ≥ 30 ml\u002Fmin\u002F1.73m2, left ventricular hypertrophy or retinopathy);\n* C. ≥ 3 major risk factors (age ≥ 65 years old, hypertension, dyslipidemia, smoking, obesity );\n* D. Diabetes duration ≥ 10 years, with any one traditional cardiovascular risk factor such as advanced age, obesity, smoking, sedentary, family history of cardiovascular disease, hypertension, abnormal lipid metabolism.\n\nExclusion Criteria:\n\n* ①Pregnant women or women planning to become pregnant;\n* ②eGFR\\\u003C30 mL\u002Fmin\u002F1.73m2 (CKD-EPI formula);\n* ③Patient cannot be followed up for 36 months (due to health condition or migration);\n* ④Unwilling or unable to sign the informed consent;\n* ⑤Type 1 diabetes;",{"count":465,"type":23},5600,[87],"The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.",[119,469,30],"Cardiovascular Complication",[471,472,473,474],"Diabetes implementation study","Diabetes guideline algorithm","Cardiovascular disease","Chronic kidney disease","2025-05-09",{"date":477,"type":46},"2025-05-14",{"date":479,"type":46},"2022-11-21",{"date":481,"type":23},"2026-11-30",{"name":483,"class":104},"Shanghai Zhongshan Hospital",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":18,"minAge":491,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":54},"100589828","oxygen-therapy-in-diabetic-kidney-disease-100589828","NCT06959485","Oxygen Therapy in Diabetic Kidney Disease","Oxygen Therapy in Diabetic Kidney Disease and Its Effect on Proteinuria and Blood Glucose Level","Inclusion Criteria:\n\n\\- Diabetic male and female patients aged \\> 18 yrs with diabetic kidney disease (eGFR 30-90 mL\u002Fmin\u002F1.73m² and proteinuria \\>300 mg\u002Fday)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 yrs\n* Cardiovascular disease (thorough assessment of the patient's medical history (symptoms suggestive of CVD (e.g., chest pain, shortness of breath, fatigue), family history of CVD and risk factors (e.g., hypertension, hyperlipidemia, smoking). Physical Examination including blood pressure measurement, auscultation of heart sounds and assessment of peripheral pulses. Additional Diagnostic Tests: Stress test (stress ECG and stress echocardiography): Evaluate cardiac function under stress, which can help detect coronary artery disease or other CVD.\n* Chronic lung disease (COPD, pulmonary fibrosis …\n* Other chronic disease affecting kidney function (lupus nephritis).\n* Pregnancy or lactation.","10 Years","17 Years",{"count":441,"type":23},[87],"Diabetic kidney disease (DKD) is the most significant cause of end-stage kidney disease (ESKD). Albuminuria, evolving from microalbuminuria to nephrotic-range proteinuria, is a clinical hallmark of diabetic nephropathy (DN). It develops in about a third of diabetic patients and is considered an independent risk factor in the progression of DN and for all-cause mortality.",[30],"2025-04-28",{"date":499,"type":46},"2025-05-06",{"date":501,"type":23},"2025-08-01",{"date":503,"type":23},"2026-08-10",{"name":505,"class":104},"Assiut University",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":514,"targetDuration":4,"studyType":24,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":54},"100581109","effect-of-acute-hypoxia-on-renal-hemodynamic-in-healthy-volunteers-patients-with-diabetes-and-patients-with-diabetes-and-kidney-disease-100581109","NCT06846034","Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease","Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.","DIAKIPOX","Inclusion Criteria:\n\nFor all participant :\n\n1. No history of respiratory diseases\n2. Affiliated person or beneficiary of the French social security scheme.\n3. signed informed consent\n\nGroup 1 ( For healthy volunteers):\n\n1. \\[18; 40\\] years old\n2. No history of diabetes\n3. No acute\u002Flong term \\> 3 months drug use except contraception\n4. BMI: \\[18,5 - 29,9\\]kg\u002Fm2\n5. eGFR \\> 60ml\u002Fmin\u002F1.73m2\n6. Normal to midly increased albuminuria: defined as ACR \\\u003C 3 mg\u002Fmmol\n\nFor all the patients with T2D (group 2 and 3):\n\n1. Diagnosed T2D according to ADA criteria\n2. \\[35; 75\\] years old\n3. Stable treatment of diabetes and\u002For antihypertension for at least 2 months prior to inclusion\n4. No proliferative diabetic retinopathy\n\nGroup 2 - For patients with T2D and no DKD:\n\n* eGFR \\> 60ml\u002Fmin\u002F1.73m2 and\n* Normal to midly increased albuminuria: defined as ACR \\\u003C 3 mg\u002Fmmol\n\nGroup 3 - For patients with DKD:\n\n* eGFR \\[45-60 ml\u002Fmin\u002F1.73m2\\] and\u002For\n* Moderately to severely increased ACR ≥ 3 mg\u002Fmmol\n\nExclusion Criteria:\n\nFor all participants:\n\n1. Active smoking\n2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.\n3. Contraindication to cardiac MRI, renal MRI, respiratory tests,\n4. History acute coronary syndrome or coronary revascularization\n5. Recent (\\\u003C6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder\n6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)\n7. Resting oxygen saturation \\\u003C95% at baseline\n8. Any concomitant disease or condition that may interfere with the safety or the possibility for the patient to comply with or complete the study protocol.\n9. History of severe mountain sickness (dizziness, headache, nausea\u002Fvomiting and incapaciting fatigue)\n10. Consumption of SGLT2 inhibitors\n11. Concurrent participation in another clinical research study\n12. Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception\n13. Persons benefiting from enhanced protection under french national law\n14. Persons under psychiatric care who are unable to give their consent",{"count":382,"type":23},[87],"Diabetes mellitus is a non-transmissible disease whose incidence is growing worldwide .\n\nThis pathology is defined by a chronic hyperglycaemia linked to a deficiency of either insulin secretion or its action or both. This increased prevalence is linked to the growing of the obese population on one hand, and to the ageing of the population, on the other hand, which is associated with an increased prevalence of metabolic diseases. The number of patients with diabetes, particularly type 2 diabetes (T2D) is regularly increasing. In France, the prevalence of diabetes is 4- 6% of the adult population.\n\nDiabetic kidney disease (DKD) is a growing public health problem and therefore constitutes a major factor in progressive kidney disease. DKD has become the leading cause of end stage kidney disease (ESKD), requiring dialysis or transplantation.\n\nCurrent routine screening for DKD is limited to detecting of impaired glomerular filtration rate (GFR) and\u002For elevated albuminuria, typically manifests in later stages of DKD. Therefore, the current methods to screen for DKD lack the resolution to capture the earliest functional changes associated with DKD.\n\nChronic renal hypoxia plays a crucial role in the development and progression of DKD and may affect Renal hemodynamic.\n\nThe aim to assess the feasibility of the measure of hypoxa-induced renal hemodynamics parameters.",[236,30,518,519,286],"Hypoxia","Healthy Volunteer","2025-04-07",{"date":522,"type":46},"2025-04-09",{"date":524,"type":46},"2025-02-13",{"date":526,"type":23},"2026-09",{"name":528,"class":104},"Poitiers University Hospital",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":54},"100568863","efficacy-and-safety-of-lc-z300-01-on-proteinuria-in-diabetic-patients-100568863","NCT06686758","Efficacy and Safety of LC-Z300-01 on Proteinuria in Diabetic Patients","A Trial Investigating the Efficacy and Safety of LC-Z300-01 on Proteinuria in Patients With Diabetic Kidney Disease","Inclusion Criteria\n\n1. Age ≥18 years.\n2. Clinically diagnosed type 2 diabetes mellitus with biopsy-proven or clinically confirmed diabetic kidney disease.\n3. HbA1c ≤9% at screening.\n4. Elevated albuminuria defined as either: uACR ≥30 mg\u002Fg on ≥2 occasions within 3 months or sustained proteinuria \\>300 mg\u002F24-hour urine collection.\n5. eGFR ≥60 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation) at baseline.\n6. Stable RAS blockade therapy meeting either: Maximum tolerated dose of ACE inhibitor\u002FARB for ≥4 weeks pre-screening or documented intolerance to ACEi\u002FARB (with nephrologist confirmation).\n7. If using SGLT2 inhibitors and\u002For nonsteroidal mineralocorticoid receptor antagonists (ns-MRAs): stable regimen ≥4 weeks pre-enrollment or commitment to maintain dosing throughout study.\n8. Capacity to provide written informed consent (self or via legally authorized representative).\n\nExclusion Criteria\n\n1. Type 1 diabetes or secondary diabetes.\n2. Acute metabolic complications within 6 months: diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), severe hypoglycemia requiring hospitalization.\n3. Various primary glomerular diseases, other secondary renal diseases (e.g. lupus nephritis, vasculitis renal damage, gouty nephropathy, obstructive nephropathy, chronic pyelonephritis, tumour-associated renal disease, polycystic kidney disease, etc.).\n4. Patients with a history of autoimmune diseases that cause renal impairment (including but not limited to systemic lupus erythematosus, systemic small vessel vasculitis, rheumatoid arthritis, ankylosing spondylitis, dry syndrome, etc.).\n5. patients who have received dialysis treatment for acute kidney injury within 6 months or who are expected to undergo dialysis during the study.\n6. patients with a history of malignancy within 5 years.\n7. participation in other clinical studies within 3 months.\n8. Pregnant or lactating women.\n9. hypersensitivity to any of the components of the interventions in this study.\n10. alcohol or other drug abuse, and other conditions deemed by the investigator to be inappropriate for participation in this study.",{"count":64,"type":23},[87],"The purpose of this RCT is to investigate the efficacy and safety of Sugar cane polysaccharide LC-Z300-01 on proteinuria in participants with diabetic kidney disease (DKD).",[30],"2025-03-28",{"date":542,"type":46},"2025-04-02",{"date":544,"type":23},"2025-04",{"date":546,"type":23},"2026-05",{"name":548,"class":104},"Shanghai Changzheng Hospital",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":17,"sex":18,"minAge":556,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":432},"100439898","puberty-diabetes-and-the-kidneys-when-eustress-becomes-distress-panther-study-100439898","NCT05008276","Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)","PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress","Inclusion Criteria:\n\n* HbA1c ≥6.0% for untreated high-risk group\n* BMI ≥ 85th %ile for high-risk group\n* Normal HbA1c ≤5.6% for control group\n* Type 1 diabetes (T1D) Antibody negative\n\nExclusion Criteria:\n\n* History of Chronic kidney disease (CKD) or acute kidney injury (AKI)\n* Metabolic disorder prohibiting safe fasting\n* Iodine or penicillin allergy\n* Pregnancy\n* Thrombophilia\n* MRI contraindications\n* Hormone therapy","8 Years","14 Years",{"count":559,"type":23},100,"Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.",[562,30,563,564,565,566],"Type 2 Diabetes Mellitus","Adolescent Obesity","Pre Diabetes","Kidney Hypoxia","Puberty","2025-03-20",{"date":569,"type":46},"2025-03-24",{"date":571,"type":46},"2021-09-27",{"date":573,"type":23},"2027-12-01",{"name":575,"class":104},"Petter Bjornstad",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":281,"enrollmentInfo":583,"targetDuration":4,"studyType":24,"phases":585,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":4},"100566881","phase-4-clinical-trial-of-keluoxin-capsules-in-the-treatment-of-diabetic-kidney-disease-with-diabetic-retinopathy-100566881","NCT06660940","Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy","A Randomized, Double-blind, Multicenter Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy","Inclusion Criteria:\n\n* Age: 18-75 years old, either sex;\n* Meeting the diagnostic criteria for type 2 diabetes mellitus and DKD;\n* The target eye met the diagnostic criteria for type 2 DR and the fundus showed moderate or severe NPDR;\n* Have been treated with an adequate dose of RAASIs for more than 4 weeks;\n* The 24h UTP between 0.5g and 3.5g (results of two tests);\n* The eGFR ≥30ml\u002Fmin\u002F1.73m2；\n* Blood pressure (BP) ≤ 140\u002F90mmHg;\n* Hemoglobin A1c (HbA1c) \\\u003C 9%;\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with a known or suspected history of allergy to the test drug and its excipients;\n* Various primary kidney diseases or non-diabetic kidney disease as judged by the investigator;\n* Heat-toxin syndrome: swelling and pain the throat , redness, swelling, and pain in the eyes, mouth and tongue sores, swollen and painful gums, cough with yellow phlegm, stool stem nod, deep colored urine, red tongue with yellow coating; cold-dampness syndrome: poor appetite, borborygmus, diarrhoea, drowsiness, clear urine in large amounts and high frequency, menstrual disorders, aversion to cold and cold limbs; meet the either manifestation of heat-toxin syndrome or cold-dampness syndrome, that is, the need to be excluded;\n* The patient's eye has any of the following conditions:\n\n  1.Target eye (if both eyes of the patient meet the inclusion criteria, the target eye will be determined by the investigator from a medical point of view. In principle, the eye with more severe lesion will be chosen as the target eye, and the eye with clearer refractive media will be chosen if the lesions are of the same degree):\n  1. Received periocular corticosteroid injections within 3 months prior to screening;\n  2. Use of Chinese patent medicines or chemical drugs with therapeutic effects on DR (e.g., Calcium Dobesilate, Difrarel, Qiming Granules, Shuangdan Mingmu Capsules) within 2 weeks prior to screening;\n  3. Suffering from other retinal diseases affecting the macula, e.g. central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), wet age-related macular degeneration (AMD), choroidal neovascularization (CNV), CI-DME, ocular ischemic syndrome, Irvine-Gass syndrome, radiation retinopathy;\n  4. Suffering from other eye diseases that affect vision, such as glaucoma, uveitis, optic neuropathy, retinal detachment;\n  5. Have undergone the following ophthalmic surgeries or treatments: vitrectomy, macular buckling, glaucoma filtration surgery, panretinal photocoagulation, macular photocoagulation, photodynamic therapy, optic neurotomy, optic nerve sheath fenestration, etc;\n  6. Undergone the following eye surgeries within 3 months prior to screening, including cataract surgery and keratoplasty;\n  7. The need for cataract surgery during the study period;\n  8. Presence of refractive medium opacity and\u002For pupillary abnormality that affect fundus photography and OCTA imaging; 2. Either eye:\n\n  \u003C!-- -->\n\n  1. Received intravitreal injection of anti-vascular endothelial growth factor (VEGF) drugs or corticosteroids within 3 months prior to screening;\n  2. Suffering from active inflammation of the eye or periocular area (e.g., hordeolum, infectious conjunctivitis, keratitis, scleritis, endophthalmitis);\n  3. Suffering from intraocular or intraorbital space-occupying lesions, and malignancy cannot be excluded.\n* Have a history of using systemic glucocorticoids and immunosuppressants within 3 months prior to enrolment;\n* Experienced active bleeding within 3 months prior to enrolment;\n* The eGFR decreased by ≥ 30% within 3 months prior to enrolment;\n* Patients with a history of unilateral or bilateral renal artery stenosis;\n* BP \\\u003C 90\u002F60 mmHg;\n* Serious acute complications of diabetes mellitus, serious infections within 4 weeks prior to enrolment;\n* Serum albumin (ALB) \\\u003C 30g\u002FL, hemoglobin ≤ 90g\u002FL;\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) reaches more than two times of the upper limit of normal level;\n* Comorbid with serious diseases of other organs such as cardiovascular disease, respiratory disease, and other serious diseases that may affect the patient's life;\n* Patients with malignancy or malignant diseases that affect the overall prognosis;\n* Pregnant and lactating women or women with childbearing plans within 6 months;\n* Those who have participated in a clinical trial of another drug within 3 months prior to randomization (referring to those who are randomized and treated with the trial drug);\n* Others who were judged by the investigator to be inappropriate for inclusion.",{"count":584,"type":23},460,[116],"The purpose of the study is to evaluate the efficacy of Keluoxin Capsules for the treatment of diabetic kidney disease (DKD) and diabetic retinopathy (DR) compared to placebo on a conventional treatment basis.",[30,588],"Diabetic Retinopathy",[422,590,591],"Keluoxin Capsules","Diabetic retinopathy","2024-10-25",{"date":594,"type":46},"2024-10-28",{"date":596,"type":23},"2024-10",{"date":598,"type":23},"2027-10",{"name":600,"class":104},"Chinese PLA General Hospital",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":618,"leadSponsor":620,"locationsCount":4},"100561510","metabolic-phenotypes-of-obesity-and-diabetic-kidney-disease-in-patients-with-type-2-diabetes-mellitus-100561510","NCT06591104","Metabolic Phenotypes of Obesity and Diabetic Kidney Disease in Patients with Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Type 2 diabetic adult patients admitted at Assiut university hospital divided into 4 groups of metabolic phenotypes according to obesity and metabolic status .\n\nExclusion Criteria:\n\n1. Age less than 18\n2. type 1 diabetes\n3. those with a BMI \\&lt;18.5 kg\u002Fm2\n4. co-existing non-diabetic renal disease\n5. Pregnancy and patients with malignancy\n6. Urinary tract infection",{"count":608,"type":23},71,"1. Comparison between the 4 groups of metabolic phenotypes of obesity as regard the presence and frequency of DKD\n2. Relation between DKD , obesity (BMI) and metabolic risk factors in patients with type 2 DM",[30,611,612,613],"Obesity","Metabolic Syndrome","Diabetes Mellitus, Type 2","2024-09-07",{"date":616,"type":46},"2024-09-19",{"date":596,"type":23},{"date":619,"type":23},"2025-10",{"name":505,"class":104},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":24,"phases":630,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":643,"leadSponsor":645,"locationsCount":432},"100550017","phase-2-clinical-outcome-of-vinpocetine-in-diabetic-nephropathy-100550017","NCT06441591","Clinical Outcome of Vinpocetine in Diabetic Nephropathy","The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy","Inclusion Criteria:\n\n* Age ≥ 18 years,\n* Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml\u002Fmin) or stage 4 (eGFR 15-29 ml\u002Fmin),\n* Albumin\u002FCreatinine ratio (ACR): 30 - 300 μg \u002Fmg (microalbuminuria),\n* Stable standard therapy for at least three months prior to inclusion in the study.\n\nExclusion Criteria:\n\n* Kidney donor or recipient,\n* Active malignancy,\n* Pregnancy or breastfeeding,\n* Known intolerance or hypersensitivity to VPN,\n* Participation in other interventional trials,\n* Patients with inadequate liver function (ALT and AST three times greater than the upper normal limits),\n* Patients with severe comorbidities\n* Patients receiving warfarin",{"count":629,"type":23},64,[66,631],"PHASE3","The goal of this controlled, randomized, clinical trial is to evaluate the effect of vinpocetine on clinical outcomes on the diabetic nephropathy patients.\n\nThe following will be evaluated; anthropometrics, kidney functions, glucose panel, lipid panel, ICAM-1, quality of life.\n\nParticipants will receive either vinpocetine or placebo, twice daily for 3 months.",[30,286],[635,636,259,637,638],"Vinpocetine","Diabetic nephropathy","UACR","ICAM","2024-07-10",{"date":641,"type":46},"2024-07-11",{"date":639,"type":46},{"date":644,"type":23},"2025-06-01",{"name":646,"class":104},"Ain Shams University",{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":18,"minAge":654,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":54},"100424092","real-world-evidence-clinical-utility-study-of-kidneyintelx-100424092","NCT04802395","Real World Evidence Clinical Utility Study of KidneyIntelX","Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease","Inclusion Criteria:\n\n* Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.\n\nExclusion Criteria:\n\n* Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.\n* Patients with eGFR \\\u003C30 or ≥ 60 ml\u002Fmin\u002F1.73m2 without albuminuria.\n* Patients with ESRD or on renal recovery treatments at time of enrollment.\n* Patients who are pregnant at the time of enrollment.\n* Patients who are currently hospitalized.\n* Patients without minimum 6 month pre-baseline KidneyIntelX medical history.\n* Patients who are currently on Enbrel.","23 Years",{"count":656,"type":23},10000,"The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.",[333,30],"2024-04-11",{"date":661,"type":46},"2024-04-12",{"date":663,"type":46},"2021-03-02",{"date":665,"type":23},"2026-12-01",{"name":667,"class":53},"Renalytix AI, Inc."]