Early stop of phase III trial evaluating SGLT2 inhibitor in CKD
The EMPA-KIDNEY trial will stop early based on a recommendation from the Independent Data Monitoring Committee, following a formal interim assessment. This formal assessment shows that the prespecified criteria for positive efficacy are met.
In EMPA-KIDNEY, the efficacy and safety of empagliflozin in adults with chronic kidney disease (CKD) is evaluated. EMPA-KIDNEY is a large, double-blind, randomized, placebo-controlled trial including >6600 adults with CKD. The primary endpoint of the trial is a composite of kidney disease progression (defined as end-stage kidney disease, a sustained decline in eGFR to below 10 mL/min/1.73 m², renal death or a sustained decline of >40% in eGFR from randomization) or CV death. Key secondary outcomes include CV death or hospitalization for HF, all-cause hospitalization and all-cause mortality.
The trial includes patients with mildly to severely reduced eGFR, with normal and increased levels of albumin, with and without diabetes, and with CKD attributable to a wide rang of underlying causes.
Results from EMPA-KIDNEY will be presented at an upcoming medical conference.