Phase III trial with SGLT2i in CKD patients stopped early due to overwhelming efficacy
The phase III Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) trial evaluating the SGLT2 inhibitor dapagliflozin will be stopped early due to overwhelming benefit in patients with chronic kidney disease (CKD) with and without diabetes. This decision was made following a recommendation from an independent Data Monitoring Committee.
The DAPA-CKD trial is an international, multi-center, double-blinded, randomized trial designed to evaluate the efficacy of dapagliflozin (10mg, once daily) compared with placebo, in addition to standard of care. The primary endpoint is worsening of renal function, defined as the composite of eGFR decline ≥50%, onset of ESKD and death from CV or renal cause. A total of 4,245 patients with CKD stages 2-4 and with elevated urinary albumin excretion, with and without T2DM were enrolled in 21 countries.
In August 2019, the FDA has granted Fast Track designation for the development of dapagliflozin to delay the progression of renal failure and prevent death from CV and renal causes in CKD patients.
Full results of the DAPA-CKD trial will be submitted for presentation at a forthcoming medical meeting.