Boehringer Ingelheim Halts Chronic Kidney Disease Trial

Boehringer Ingelheim recently announced that the Phase 3 clinical trial studying empagliflozin in adults with chronic kidney disease (CKD) will stop early based on a recommendation from the trial's Independent Data Monitoring Committee.

The decision to halt the EMPA-KIDNEY trial comes at the heels of an assessment from the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim, and Eli Lilly and Company, which met prespecified criteria for positive efficacy.

The double-blind, randomized EMPA-KIDNEY clinical trial enrolled 6,600 adults with CKD.2, with mildly to severely reduced eGFR, with normal and increased albumin levels, with and without diabetes, and with CKD attributable to a wide range of underlying causes.

Currently, the MCR Population Health Research Unit at the University of Oxford is conducting, analyzing, and reporting the trial outcomes. The trial's primary endpoint is a composite of kidney disease progression or cardiovascular death.

Key secondary trial outcomes include cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality.

EMPA-KIDNEY follows the landmark EMPA-REG OUTCOME and EMPEROR trials, all of which demonstrated cardio-renal benefits of empagliflozin. EMPA-REG OUTCOME was the first SGLT2 inhibitor cardiovascular outcome trial to show benefits in cardiovascular and kidney outcomes in type 2 diabetes patients with cardiovascular disease on the standard of care.

Boehringer Ingelheim will present full trial results in the coming weeks.

"We are thrilled that the trial has shown that empagliflozin is beneficial among the patients studied in EMPA-KIDNEY," Richard Haynes, professor and co-principal investigator, said in the announcement. "We are very grateful to all of the participants who have made this trial possible and look forward to sharing detailed trial results later this year."   

Kidney disease is a global public health issue that affects nearly 850 million people. CKD is a leading cause of death globally and doubles an individual's risk for hospitalization.

CKD can sometimes progress to kidney failure. Kidney failure affects almost 750,000 people per year in the US. Individuals affected by kidney failure are also at high risk of cardiovascular disease, including heart disease and stroke. 

Last year, FDA approved AstraZeneca's Farxiga oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with CKD.

FDA first approved Farxiga in 2014 to improve glycemic control in adults with type 2 diabetes.