Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease
Status:
Not yet recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
Summary
This is an investigator-led, randomized, open-label, blinded-endpoint, multicenter study that
will include a total of approximately 225 subjects from 3 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
end point is eGFR decline 12-52 weeks after randomization between 2 arms.