A phase 3 trial investigating the effect of empagliflozin in adults with chronic kidney disease (CKD) will be stopped early based on data indicating a clear benefit.
The randomized, placebo-controlled EMPA-KIDNEY study (ClinicalTrials.gov Identifier: NCT03594110) enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes. The study population included patients with or without diabetes, with mildly to severely reduced eGFR, and with normal and increased levels of albumin.
The primary composite end point of the study was the time to first occurrence of kidney disease progression (defined as end-stage kidney disease, a sustained decline in eGFR to <10mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from randomization) or cardiovascular (CV) death.
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An interim assessment showed that the trial, which is being conducted, analyzed and reported by the MRC Population Health Research Unit at the University of Oxford, met prespecified criteria for positive efficacy. “We are thrilled that the trial has shown that empagliflozin is beneficial among the patients studied in EMPA-KIDNEY,” said Professor Richard Haynes, co-principal investigator.
Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is marketed under the brand name Jardiance® and is currently indicated to improve glycemic control as an adjunct to diet and exercise in adults with type 2 diabetes mellitus (T2DM); to reduce the risk of CV death in adults with T2DM and established CV disease; and to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction.
In March 2020, the Food and Drug Administration granted Fast Track designation to empagliflozin to reduce the risk of kidney disease progression and CV death in adults with CKD.
“EMPA-KIDNEY included a range of adults with kidney disease who have been excluded from, or under-represented in, previous trials focusing on the use of SGLT2 inhibitors to slow kidney disease progression,” said Jeff Emmick, MD, PhD, vice president, Product Development, Lilly. “The early stop of the trial is a tremendous step toward our goal of improving the lives of adults living with kidney disease.”
According to the Company, full results from the trial will be presented at a medical congress later this year.
Reference
Jardiance® phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease. News release. Accessed March 16, 2022. https://www.prnewswire.com/news-releases/jardiance-phase-iii-empa-kidney-trial-will-stop-early-due-to-clear-positive-efficacy-in-people-with-chronic-kidney-disease-301504008.html
This article originally appeared on MPR
