Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease

Sponsor
Kaohsiung Medical University
Study ID
NCT05196347
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    In dapagliflozin arm, subjects will be received dapagliflozin 5 mg for 4 weeks. Uptitration to 10 mg will be done between 5 to 12th weeks, if eGFR dip \<20%.

Study Details

This is an investigator-led, randomized, open-label, blinded-endpoint, multicenter study that will include a total of approximately 180 subjects from 2 sites. Subjects with an estimated glomerular filtration rate (eGFR) of 10 to 30 mL/min/1.73m2 will be included. The goal of this study is to assess the efficacy and safety of dapagliflozin (Forxiga®, AstraZeneca) in reducing renal function progression and complications of chronic kidney disease (CKD) in patients with CKD stage 4 and 5 under the integrated CKD care. Subjects will be allocated to integrated CKD care program + dapagliflozin or integrated CKD care program alone. The primary endpoint is eGFR decline after randomization between 2 arms. The secondary endpoints are renal and cardiovascular composite outcomes.

Key Dates

Start date
May 27, 2022
Status verified
Mar 2025
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
180 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: dapagliflozin + integrated CKD care program
    Subjects will be received dapagliflozin 5 mg for 4 weeks. Uptitration to 10 mg will be done between 5 to 12th weeks, if eGFR dip \<20%. In both arms, the integrated CKD care program includes CKD stage 4 and 5 education, diet counseling, bioimpedance and echocardiography measurements to control overhydration at 0-1 liter (by body composition monitor (BCM; Fresenius))
  • Active Comparator: integrated CKD care program
    In both arms, the integrated CKD care program includes CKD stage 4 and 5 education, diet counseling, bioimpedance and echocardiography measurements to control overhydration at 0-1 liter (by body composition monitor (BCM; Fresenius))

Primary Outcome Measure

eGFR slope [ Time Frame: from randomization to renal replacement therap, study completion or censoring event, upto 96 weeks ]

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