[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polycystic-kidney-autosomal-dominant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polycystic-kidney-autosomal-dominant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100614514","phase-3-stop-pkd-sglt2-inhibition-to-improve-prognosis-in-polycystic-kidney-disease-100614514",false,"NCT07280585","STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease","STOP-PKD","Inclusion Criteria:\n\n* Male and female patients with ADPKD (modified Ravine criteria) ≥ 18 and ≤ 60 years\n* Patients 18 - 39 years: eGFR ≥25 ml\u002Fmin; patients 40 - 60 years: eGFR ≥25 and \\\u003C90 ml\u002Fmin\u002F1.73 m2\n* Indicators of rapid progression, either of the following:\n* Mayo class 1D-E\n* Mayo class 1C AND EITHER\n\n  1. Truncating PKD1 mutation OR\n  2. eGFR loss \\> 3ml\u002Fmin\u002Fyear (determined by ≥ 4 creatinine values within 4 years, ≥ 6 months measurement intervals) OR\n  3. PROPKD score \\> 6 (patient history)\n* IF patient is on ACE-I \u002FARBs: stable dose for 4 weeks before screening\n\nExclusion Criteria:\n\n* Treatment with tolvaptan, somatostatin analogue, lithium or SGLT2i within the last 3 months before screening\n* Medical history of diabetic ketoacidosis, necrotizing fasciitis or organ transplantation\n* Diabetes mellitus type 1 or any type of diabetes mellitus due to insulin deficiency\n* Uncontrolled ongoing urinary tract or genital infections\n* Known intolerance of the study medication ingredients\n* Uncontrolled grade 2 hypertension (\\>160\u002F100 mmHg)\n* Symptomatic hypotension, or systolic blood pressure \\\u003C90 mmHg\n* Primary renal disease other than ADPKD\n* Hepatic impairment (aspartate transaminase \\[AST\\] or alanine transaminase \\[ALT\\]\\>3x the up-per limit of normal \\[ULN\\]; or total bilirubin \\>2x ULN at time of enrolment)\n* Pregnancy, breastfeeding or women of child-bearing potential not using effective contraception method\n* Not able to comply with the study protocol, in the investigator's judgement\n* Not able to provide informed consent\n* Participation in any other interventional clinical trial in the last 2 months","ALL","18 Years","60 Years",{"count":20,"type":21},420,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Autosomal dominant polycystic kidney disease is the most common genetic cause of kidney failure. The only approved treatment for ADPKD - tolvaptan - is limited in its use by massive therapy-associated polyuria. This trial tests if the SGLT2-inhibitor dapagliflozin slows down the loss of kidney function in ADPKD.",[27],"Polycystic Kidney, Autosomal Dominant",[14,29,30,31,32,33,34,35,36,37],"ADPKD","Dapagliflozin","SGLT2","PKD","polycystic kidney disease","SGLT2i","sodium-glucose","sodium glucose","Phase 3","RECRUITING","2026-06-12",{"date":41,"type":42},"2026-06-15","ACTUAL",{"date":44,"type":42},"2025-12-16",{"date":46,"type":21},"2030-05-15",{"name":48,"class":49},"University of Cologne","OTHER",30]