[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-nephropathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-nephropathies":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,84,118,141,170,198,221,252,285,310,337,356],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100593731","epithelial-dysmetabolism-and-renal-fibrosis-in-anca-vasculitis-100593731",false,"NCT07010250","Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis","PROTECT-Fi","Inclusion Criteria:\n\n* Patients with an indication for initial diagnostic PBR on native kidney\n* 18 ans ≥ Age ≤ 90 ans\n* Affiliation to french health insurance\n* Patient having given consent\n\nFor the ANCA vasculitis group:\n\n• Diagnosis of ANCA vasculitis retained on renal biopsy with ANCA anti-proteinase 3 (PR3) or ANCA anti-myeloperoxidase (MPO)\n\nFor the control groups:\n\n• Diagnosis retained after the renal biopsy\n\n* Interstitial Nephritis\n* Or glomerular nephropathy such as minimal change nephropathy\n* Or Segmental hyalinosis in itscollapsing form\n* Or Extramembranous Glomerulopathy,\n* Or glomerulopathy with mesangial IgA deposits\n* Or diabetic nephropathy.\n\nExclusion Criteria:\n\n* Kidney transplant patient\n* Patient on dialysis (hemodialysis or peritoneal dialysis)\n* Patient under legal protection, guardianship or curatorship\n* Pregnancy or breastfeeding\n* Enrollement in an interventional study except studies relating to ANCA vasculitis and nephropathy with mesangial IgA deposits.","ALL","18 Years","90 Years",{"count":20,"type":21},146,"ESTIMATED","OBSERVATIONAL","The project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.",[25,26,27,28,29,30,31],"ANCA Associated Vasculitis","Extramembranous Glomerulopathy","Nephrotic Syndrome, Minimal Change","Interstitial Nephritis","IgA Nephropathy","Segmental Hyalinosis","Diabetic Nephropathies",[33,34],"nephropathy","cohort","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-11-03",{"date":43,"type":21},"2029-11-02",{"name":45,"class":46},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100551903","phase-2-study-of-wal0921-in-patients-with-glomerular-kidney-diseases-100551903","NCT06466135","Study of WAL0921 in Patients With Glomerular Kidney Diseases","Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria","Inclusion Criteria:\n\n* Adults, age 18-75 years\n* Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy\n* eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73 m2\n\nExclusion Criteria:\n\n* Currently pregnant or planning to become pregnant\n* History of organ transplantation\n* History of alcohol or substance use disorder\n* Acute dialysis or acute kidney injury within 6 months of Screening\n* Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and\u002For completing all study requirements","75 Years",{"count":57,"type":21},96,"INTERVENTIONAL",[60],"PHASE2","This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \\[FSGS\\], treatment-resistant minimal change disease \\[TR MCD\\], primary immunoglobulin A nephropathy \\[IgAN\\], and primary membranous nephropathy \\[PMN\\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.",[31,63,64,65,66],"Primary Focal Segmental Glomerulosclerosis","Minimal Change Disease","Primary Immunoglobulin A Nephropathy","Primary Membranous Nephropathy",[68,69,70,71,72],"DN","FSGS","TR-MCD","IgAN","PMN","2026-03-27",{"date":75,"type":39},"2026-04-02",{"date":77,"type":39},"2024-07-02",{"date":79,"type":21},"2027-06",{"name":81,"class":82},"Walden Biosciences","INDUSTRY",50,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":92,"targetDuration":4,"studyType":58,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100532783","phase-3-sotagliflozin-to-slow-kidney-function-decline-in-persons-with-type-1-diabetes-and-diabetic-kidney-disease-100532783","NCT06217302","Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease","Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease","SUGARNSALT","Inclusion Criteria:\n\n* Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.\n* Duration of T1D ≥ 8 years;\n* eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml\u002Fmin\u002F1.73 m2 at screening (with the option of a second eGFR measurement within 4 weeks from the first one if the eGFR was in the range of \\>60 to ≤65 or ≥16 to \\\u003C20 ml\u002Fmin\u002F1.73 m2);\n* a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg\u002Fg at Screening or on repeat measurement within 4 weeks from the first one, or b. First morning void urinary UACR ≥100 mg\u002Fg at Screening or on repeat measurement within 4 weeks and at least one uACR \\>=30 in the previous 2 years while treated with RASB at a stable dose;\n* HbA1c at screening \\\u003C10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);\n* Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, unless contraindicated or not tolerated.\n* Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study.\n* a. Blood pressure ≤155\u002F95 mmHg at screening, or b. BP ≤155\u002F95 mmHg at the end of the run-in period, or c. consistent BP ≤155\u002F95 mmHg on home monitoring during the run-in period, as determined by study site investigator, despite BP values \\>155\u002F95 mmHg in clinic.\n\nExclusion Criteria:\n\n* Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;\n* Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;\n* Use of any SGLT inhibitor in the previous 2 months;\n* Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);\n* Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \\> 2 months at screening (patients can be rescreened after being on stable dose for \\> 2 months);\n* Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;\n* Known allergies, hypersensitivity, or intolerance to SOTA;\n* History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;\n* History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR \\>1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;\n* Blood beta-hydroxybutyrate (BHB) \\>0.6 mmol\u002FL for \\>2 hours on \\>2 occasions during the Run-in period;\n* Inadequate beta hydroxybutyrate (BHB) testing (\\\u003C50% of the prescribed measurements) during Run-in;\n* History of primary renal glycosuria;\n* History of biopsy-proven non-diabetic chronic kidney disease (CKD);\n* History of kidney transplant or currently on chronic dialysis;\n* Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and\u002For aspartate aminotransferase (AST) or alanine transaminase (ALT) at screening \\>2 times upper limit of normal, and\u002For total bilirubin at screening \\>1.3 times upper limit of normal).\n* History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;\n* Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.\n* Illicit drug abuse within 6 months of screening;\n* Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);\n* Participation in another interventional clinical research study within 30 days of screening;\n* Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;\n* Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;\n* Any condition that may render the patient unable to comply with study requirements and\u002For complete the study.",{"count":93,"type":21},150,[95],"PHASE3","Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50\u002F50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.",[31,98,99,100],"Kidney Failure, Chronic","Diabetes Mellitus Type 1","Heart Failure",[31,98,102,103,104,105,106,107],"Type 1 diabetes","Heart failure","Cardiovascular disease","Glomerular filtration rate","SGLT2 inhibitors","Diabetic kidney disease","2026-03-20",{"date":110,"type":39},"2026-03-24",{"date":112,"type":39},"2024-10-31",{"date":114,"type":21},"2029-05",{"name":116,"class":46},"Alessandro Doria",19,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":55,"enrollmentInfo":126,"targetDuration":128,"studyType":22,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100626426","irisin-hormone-as-a-novel-diagnostic-marker-for-detection-and-progression-of-diabetic-nephrophathy-patients-100626426","NCT07435480","Irisin Hormone as a Novel Diagnostic Marker for Detection and Progression of Diabetic Nephrophathy Patients","Evaluation of Irisin as a Novel Diagnostic Marker for Early Detection and Progression of Diabetic Nephrophathy","Inclusion Criteria:\n\nType 2 diabetic patients\n\nExclusion Criteria:\n\n* Non-diabetic kidney diseases.\n* Acute illness, infection, obesity, hypertension, type 1 DM.\n* Malignancy, other endocrine disorders, corticosteroid drugs, pregnancy, lactation.","30 Years",{"count":127,"type":21},200,"2 Months","Study the relation between irisin level and progression of diabetic nephropathy and its early detection.",[31],"NOT_YET_RECRUITING","2026-03-07",{"date":134,"type":39},"2026-03-10",{"date":136,"type":21},"2026-04-01",{"date":138,"type":21},"2028-03-01",{"name":140,"class":46},"Sohag University",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":167,"locationsCount":169},"100284775","transformative-research-in-diabetic-nephropathy-100284775","NCT02986984","Transformative Research in Diabetic Nephropathy","Transformative Research In DiabEtic NephropaThy","TRIDENT","Inclusion Criteria:\n\n* Type 1 and 2 Diabetes by American Diabetes Association (ADA) criteria\n* Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site\n* Able to provide informed consent\n* Adult participants\n* Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist\n\nExclusion Criteria:\n\n* End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant\n* History of receiving dialysis for more than 30 days prior to biopsy\n* Institutionalized\n* Solid organ or bone marrow transplant recipient at time of first kidney biopsy\n* Less than 3-year life expectancy\n* History of active alcohol and\u002For substance abuse that in the investigator's assessment would impair the subject's ability to comply with the protocol\n* Unable to provide informed consent\n* Evidence of active cancer requiring treatment, other than non-melanoma skin cancer","100 Years",{"count":151,"type":21},400,"This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (\\> 5 mL\u002Fmin\u002F1.73m2\u002Fyear) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.",[31,154],"Diabetic Glomerulosclerosis",[156,157,158,159,160],"Diabetes","Chronic kidney disease","Progression","Genomics","Transcriptomics","2026-02-25",{"date":163,"type":39},"2026-02-27",{"date":165,"type":39},"2016-12",{"date":79,"type":21},{"name":168,"class":46},"University of Pennsylvania",17,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":47},"100627097","transformative-research-in-diabetic-nephropathy-20-100627097","NCT07444203","Transformative Research in Diabetic Nephropathy 2.0","Transformative Research in Diabetic Nephropathy 2.0: A Proof of Principle Study of SGLT2 Inhibitors (TRIDENT 2.0)","TRIDENT 2","Inclusion Criteria:\n\n* Age ≥18 years\n* eGFR ≥10 ml\u002Fmin\u002F1.73 m2 based on the 2021 race-free CKD-EPI equation13\n* Underwent a clinically indicated kidney biopsy, living donor biopsy, or nephrectomy (non-tumor adjacent tissue available).\n* Able and willing to provide informed consent for release of one pathology and clinical data abstraction.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Archived biopsy or surgical tissue unavailable for slide preparation.\n* Any local institutional policy that prohibits release of H\\&E slides for research.",true,{"count":127,"type":21},"The goal of this observational study is to learn more about kidney health in adults with diabetic kidney disease and other groups. Researchers will study kidney tissue and other samples. They want to learn how sodium-glucose cotransporter-2 (SGLT2) inhibitors, a type of diabetes medicine, may affect the kidneys. People can join only if they are already having a kidney biopsy or kidney surgery as part of their regular medical care.\n\nThe main questions this study aims to answer are:\n\n* Do people who take SGLT2 inhibitors show different biological patterns in kidney tissue than similar people who do not take them?\n* Are these kidney tissue patterns linked with how kidney health changes over time?\n\nResearchers will compare participants who take SGLT2 inhibitors with similar participants who do not take these medicines.\n\nParticipants will:\n\nLet researchers use one stored slide of kidney tissue from their regular care (no extra research biopsy) Give a blood sample and a urine sample Let researchers review medical record information over time",[31,182,183,184],"Kidney Diseases","Renal Insufficiency, Chronic","Diabetes Mellitus, Type 2",[186,157,107,187,188,189],"Diabetic nephropathy","Sodium-glucose cotransporter 2 inhibitors","Spatial transcriptomics","Kidney-protective therapy","2026-02-24",{"date":192,"type":39},"2026-03-02",{"date":194,"type":39},"2025-11-12",{"date":196,"type":21},"2028-11-12",{"name":168,"class":46},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":205,"targetDuration":4,"studyType":58,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":47},"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",{"count":206,"type":21},120,[60],"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.",[31,210],"Diabetic Kidney Disease",[156],"2026-02-03",{"date":214,"type":39},"2026-02-05",{"date":216,"type":39},"2025-12-01",{"date":218,"type":21},"2027-11",{"name":220,"class":46},"Medical University of South Carolina",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":232,"conditions":233,"keywords":239,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":5},"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":231,"type":21},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.",[234,235,210,31,236,237,238],"Chronic Kidney Diseases","Albuminuria","Diabetes type2","Molecular Sequence Variation","Kidney Biopsy",[240,241,242],"diabetic nephropaty","precision medicine","kidney biopsy","2025-12-17",{"date":245,"type":39},"2025-12-24",{"date":247,"type":39},"2021-08-10",{"date":249,"type":21},"2043-12-31",{"name":251,"class":46},"Herlev Hospital",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":58,"phases":262,"briefSummary":264,"conditions":265,"keywords":273,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":47},"100607373","phase-4-ace-reno-pico-cell-matrix-and-its-effect-on-egfr-in-chronic-kidney-diseases-100607373","NCT07187713","ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases","ACE Reno, Effect of Pico Cell Matrix on Patients With Micro-albuminuria, Proteinuria or CKD (of Any Degree) Due to Diabetes Mellitus, Autoimmune, Miscellaneous Aetiology","ACE Reno","Inclusion Criteria:\n\n* Adults (≥18 years) with nephropathy of any degree (microalbuminuria, overt proteinuria, CKD stages 1-5 not on dialysis, or post-transplant with proteinuria). Stable background therapy with ACEi\u002FARB, SGLT2i, or MRA allowed.\n\nExclusion Criteria:\n\n* Recent kidney transplant (\\\u003C12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.","80 Years",{"count":231,"type":21},[263],"PHASE4","This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages. The trial evaluates whether 12 weeks of ACE Reno (1 mL sublingually four times daily) reduces albuminuria\u002Fproteinuria and stabilizes kidney function in participants with nephropathy due to diabetes, hypertension, autoimmune disease, reflux\u002FUTI, chronic glomerulonephritis, unknown etiology, pre-dialysis CKD, or post-transplant proteinuria.\n\nNephropathy remains a global health burden, with \\~9-10% of the population affected by chronic kidney disease (CKD), equating to \\>750 million individuals worldwide. The socioeconomic costs are substantial: in England CKD costs \\~£7 billion annually, projected to rise to \\~£14 billion by 2033; in Malaysia, prevalence rose from 9% to 15.5% within 7 years; in Egypt, CKD imposes heavy familial and financial burdens, especially for pediatric patients; in Turkey, CKD is among the top causes of disability, linked to the rising tide of diabetes, obesity, and hypertension.\n\nACE Reno is designed to address multiple drivers of CKD progression - glomerulosclerosis, fibrosis, endothelial dysfunction, and maladaptive RAAS\u002Faldosterone signaling - through its peptide components that mimic antifibrotic (BMP-7, HGF, Klotho-like) and vasodilatory\u002FcGMP-mediated (natriuretic peptide-like) pathways.",[266,267,268,269,270,271,272,31],"Hypertensive Nephropathy","Auto Immune Disorders","Chronic Kidney Disease","Chronc Kidney Disease Stage 5","Chronic Kidney Disease (Stage 3-4)","Chronic Kidney Disease (Stages 4 and 5)","Microalbuminuria",[274,275,33],"chronic kidney disease","ckd","2025-09-19",{"date":278,"type":39},"2025-09-23",{"date":280,"type":21},"2025-09-20",{"date":282,"type":21},"2026-12-31",{"name":284,"class":82},"Ace Cells Lab Limited",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":178,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":293,"targetDuration":4,"studyType":58,"phases":295,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":47},"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":294,"type":21},30,[296],"NA","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.",[156,210,299,300,31],"Hypoxia","Healthy Volunteer","2025-04-07",{"date":303,"type":39},"2025-04-09",{"date":305,"type":39},"2025-02-13",{"date":307,"type":21},"2026-09",{"name":309,"class":46},"Poitiers University Hospital",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":58,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100527397","phase-2-prevention-of-chronic-kidney-diseasecdk-progression-in-type-1-diabetes-with-long-term-use-of-sodium-glucose-cotransporter-inhibitors-avoiding-kidney-hypoxia-100527397","NCT06147232","Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia","Prevention of CKD Progression in Type 1 Diabetes With Long Term Use of SGLTi Avoiding Kidney hypOxia(PLUTO)","PLUTO","Inclusion Criteria:\n\n1. Persons ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \\\u003C40 years; permanent insulin treatment initiated within 1 year of diagnosis)\n2. Albuminuria: UACR \\> 100 mg\u002Fg (in ≥2 out 3 morning spot urine collections prior to randomization)\n3. estimated Glomerular Filtration Rate(eGFR) ≥25 and \\\u003C 75 ml\u002Fmin\u002F1.73m2\n4. Participants must be on stable renin-angiotensin system blocking treatment 4 weeks before start of study drug and throughout study duration.\n5. Able to understand the written participant information and give informed consent\n\nExclusion Criteria:\n\n1. Non-diabetic kidney disease indicated by medical history and\u002For laboratory findings.\n2. eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2, dialysis or kidney transplantation.\n3. Previous diabetic ketoacidosis, except at debut.\n4. Dysregulated diabetes (HbA1c \\> 85 mmol\u002Fmol)\n5. Decreased awareness or unawareness\n6. Pregnancy, lactating or with a wish of pregnancy within the next year\n7. Low carbohydrate diet\n8. Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT inhibitor.\n9. New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment\n10. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment\n11. The receipt of any investigational product 90 days prior to this trial\n12. Unable to participate in study procedures\n13. Any clinically significant disorder, except for conditions associated with type 1 diabetes, which in the Investigators opinion could interfere with the results of the trial\n14. Participation in another intervention study\n15. Exclusion criteria for MRI: known claustrophobia, known chronic lung disease, surgery within past 6 weeks or having foreign bodies of metal in the body (e.g. pacemaker, metal plates, metal screws)\n16. Recurrent urogenital infections.",{"count":319,"type":21},69,[60],"Background: Sodium-glucose-cotransporter (SGLT) inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes. People with type 1 diabetes also have increased risk of cardiovascular and kidney disease, and may benefit from SGLT-inhibition. The exact mechanism of how SGLT-inhibition benefits the kidneys are yet unknown. Change in renal hypoxia may be a factor.\n\nObjective: The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease.\n\nFurther aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent.\n\nAdditionally effects on left ventricular ejection fraction, kidney function and biomarkers in blood and urine will be explored.\n\nMethod: 12 weeks treatment with oral sotagliflozin or matching placebo as intervention. Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging. Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines.\n\nDesign: Randomized, double-blinded, placebo-controlled, cross over intervention study.\n\nStudy population: 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included, 39 at Steno Diabetes Center Copenhagen, 30 at King's College London.\n\nEndpoints: Primary end-point: Change from 0 to 12 weeks in dynamic R2\\*-weighted signal after treatment with sotagliflozin compared to placebo. Secondary endpoints: Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion, renal artery flow, renal oxygen consumption, renal parenchymal triglyceride fraction, renal fibrosis, left ventricular ejection fraction, urinary albumin-creatinin ratio, ketone bodies, erythropoietin, pro brain natriuretic peptide, and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate.\n\nTimeframe: Inclusion of patients from february 2024. Last visit september 2025. Presentation spring 2026, publication fall 2026.",[323,31,324,235,325,326,299],"Nephropathy","Diabetes Mellitus, Type 1","Diabetic Complications Renal","Diabetic Complications Cardiovascular","2025-01-22",{"date":329,"type":39},"2025-01-27",{"date":331,"type":21},"2025-02",{"date":333,"type":21},"2027-05",{"name":335,"class":46},"Steno Diabetes Center Copenhagen",2,{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100559412","assessment-of-the-association-between-visceral-obesity-and-the-progression-of-diabetic-nephropathy-100559412","NCT06563791","Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy","Inclusion Criteria:\n\n\\- 1. Diabetic patients either type 1 or type 2 diabetes aged \\> 18 years whether known to have diabetic nephropathy or not.\n\n2\\. BMI is ≥ 25 kg\u002Fm2\n\nExclusion Criteria:\n\n* 1\\. Patients age \\\u003C 18 years. 2. BMI \\\u003C 25 kg\u002Fm2 3. Nondiabetic patients 4. Patients with non-diabetic kidney disease. 5. Patients with AKI 6. Patients with CKD stage 5 either on dialysis or not.",{"count":344,"type":21},100,"Assessment of the association between visceral obesity and the progression of diabetic nephropathy",[31],"2024-08-18",{"date":349,"type":39},"2024-08-21",{"date":351,"type":21},"2024-09",{"date":353,"type":21},"2025-10",{"name":355,"class":46},"Assiut University",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":58,"phases":365,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":336},"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":364,"type":21},64,[60,95],"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.",[210,31],[369,186,370,371,372],"Vinpocetine","diabetic kidney disease","UACR","ICAM","2024-07-10",{"date":375,"type":39},"2024-07-11",{"date":373,"type":39},{"date":378,"type":21},"2025-06-01",{"name":380,"class":46},"Ain Shams University"]