Trial with GLP-1RA in T2D and CKD stopped early after meeting efficacy criteria
The FLOW trial, a dedicated kidney outcomes trial with semaglutide in patients with T2D and CKD, will be stopped early due to meeting pre-specified efficacy criteria in the interim analysis.
FLOW is a randomized, double-blind, placebo-controlled, superiority trial which enrolled 3534 patients with T2D and CKD in 28 countries at more than 400 investigator sites. Patients were randomized to injectable semaglutide 1.0 mg once weekly or matching placebo. The composite primary endpoint consists of onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI equation compared with baseline, onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis or kidney transplantation), death from kidney disease or death from cardiovascular disease. Key secondary endpoints were annual rate of change in eGFR1 (CKD-EPI2), MACE (defined as non-fatal MI, non-fatal stroke, cardiovascular death) and all-cause death.
The results of FLOW are expected in the first half year of 2024.