Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease

Summary

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.

Timeline

Start

2022-05-27

Primary completion

2024-08-31

Completion

2024-08-31

Drugs

Indications