[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-failure-in-children-and-young-adults\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-failure-in-children-and-young-adults":28},{"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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100511790","phase-3-phase-3-clinical-trial-with-dapagliflozin-in-chronic-kidney-disease-in-adolescents-and-young-adult-patients-100511790",false,"NCT05944016","Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients","DOUBLE PRO-TECT Alport: a Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients with Alport Syndrome","DOUBLE_PROTECT","Key inclusion criteria:\n\nEarly stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening)\n\n* adolescents ≥ 10 to \\\u003C 18 years with albuminuria (UACR ≥ 300mg\u002Fg creatinine) AND\n* eGFR ≥ 30 ml\u002Fmin\u002F1.73 m2 OR\n* adults ≥ 18 to \\\u003C 40 years with albuminuria (UACR ≥ 500mg\u002Fg creatinine) AND\n* eGFR ≥ 60 ml\u002Fmin\u002F1.73 m2\n\n  1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy\n  2. Stable RAS blockade as background therapy.\n  3. Signed and dated written informed consent.\n\nKey exclusion criteria:\n\n1. Medical history that might limit the individual's ability to take trial treatments.\n2. Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.\n3. eGFR\\\u003C60 mL\u002Fmin\u002F1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation\n4. Uncontrolled arterial hypertension (blood pressure above 145\u002F95 mmHg).\n5. Known hypersensitivity or allergy to the investigational products.\n6. Any previous or current alcohol or drug abuse.\n7. Participation in another trial with an investigational drug ongoing.\n8. Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.","ALL","10 Years","39 Years",{"count":21,"type":22},102,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.",[28],"Chronic Kidney Failure in Children and Young Adults",[30,31,32,33,34],"chronic kidney disease in children","pediatric population","nephroprotective therapy in children","Alport syndrome","type IV collagen disease","RECRUITING","2024-12-11",{"date":38,"type":39},"2024-12-16","ACTUAL",{"date":41,"type":39},"2024-03-25",{"date":43,"type":22},"2026-12",{"name":45,"class":46},"University Hospital Goettingen","OTHER",16]