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Clinical Trial Details

Trial ID: L0025
Source ID: NCT05196347
Associated Drug: Dapagliflozin
Title: Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease
Acronym: DAPA-advKD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Dapagliflozin
Outcome Measures: Primary: eGFR slope, eGFR decline after randomization between 2 arms, from randomization to renal replacement therap, study completion or censoring event, upto 96 weeks | Secondary: Renal composite outcome, 1. Cardiovascular or renal death. 2. ESRD: sustained eGFR \<5 mL/min/1.73m2, chronic dialysis or renal transplantation. 3. \>50% sustained decline in eGFR (by the Modification of Diet in Renal Disease equation)., from randomization to study completion or censoring event, upto 96 weeks|Renal and heart failure composite outcome, 1. renal composite outcome 2. Acute kidney injury (increase in serum creatinine ≥1.5 times baseline within 7 days). 3. Hospitalization for heart failure., from randomization to study completion or censoring event, upto 96 weeks|Renal and cardiovascular composite outcome, 1. Renal and heart failure composite outcome. 2. 5P-Major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary/peripheral artery revascularization)., from randomization to study completion or censoring event, upto 96 weeks
Sponsor/Collaborators: Sponsor: Kaohsiung Medical University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 180
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-05-27
Completion Date: 2024-08-31
Results First Posted:
Last Update Posted: 2025-03-13
Locations: Chi-Chih Hung, Kaohsiung, Taiwan
URL: https://clinicaltrials.gov/show/NCT05196347