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Clinical Trial Details

Trial ID: L1315
Source ID: NCT05944016
Associated Drug: Dapagliflozin
Title: Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Acronym: DOUBLE_PROTECT
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Failure in Children and Young Adults
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Primary endpoint, Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks, 48 weeks | Secondary: Key secondary efficacy endpoint, Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment), 52 weeks|Key secondary safety endpoint, Adverse events (including serious adverse events), 52 weeks|Adverse events (AE) of special interest, (a) Ketoacidosis or symptomatic hypoglycemic event., 52 weeks|Adverse events (AE) of special interest, (b) Hyperkalemia (potassium levels ≥15% of the upper normal limit), 52 weeks|Adverse events (AE) of special interest, (c) Decline in eGFR of ≥ 30% relative from baseline eGFR., 52 weeks
Sponsor/Collaborators: Sponsor: University Hospital Goettingen | Collaborators: German Research Foundation
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 102
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-25
Completion Date: 2026-12
Results First Posted:
Last Update Posted: 2024-12-16
Locations: Universitätsklinikum Heidelberg - Children, Heidelberg, Baden-Württenberg, 69120, Germany|LMU Klinikum, München, Bayern, 80336, Germany|v. Haunersches Kinderhospital, München, Bayern, 81337, Germany|Clementine Kinderhospital, Frankfurt, Hessen, 60316, Germany|University Medicine Goettingen - Adults, Göttingen, Lower Saxony, 37075, Germany|University Medicine Goettingen - Childrens Hospital, Göttingen, Lower Saxony, 37075, Germany|Universitätsklinik Köln - Adults, Köln, Nordrhein-Westfalen, 50937, Germany|Universitätsklinik Köln - Children, Köln, Nordrhein-Westfalen, 50937, Germany|Universitätsklinik Münster - Adults, Münster, Nordrhein-Westfalen, 48149, Germany|Universitätsklinikum Münster - Children, Münster, Nordrhein-Westfalen, 48149, Germany|Universitätsklinik Leipzig - Children, Leipzig, Sachsen, 04103, Germany|Universitätsklinikum Leipzig - Adults, Leipzig, Sachsen, 04103, Germany|Charite Berlin - Adults, Berlin, 10117, Germany|Charite Berlin - Children, Berlin, 10117, Germany|Universitätsklinikum Hamburg-Eppendorf - Adults, Hamburg, 20246, Germany|Universitätsklinikum Hamburg-Eppendorf - Children, Hamburg, 20251, Germany
URL: https://clinicaltrials.gov/show/NCT05944016