Boehringer Ingelheim, Lilly Halt Jardiance Chronic Kidney Disease Phase 3 Trial, Citing Positive Results

Trial of empagliflozin (Jardiance) in adults with chronic kidney disease will end early based on a recommendation from the trial’s Independent Data Monitoring Committee based on clear positive efficacy.

Boehringer Ingelheim and Eli Lilly and Company (Lilly) have announced that the EMPA-KIDNEY trial, which was evaluating the effects of empagliflozin (Jardiance) in adults with chronic kidney disease (CKD), will end early based on a recommendation from the trial’s Independent Data Monitoring Committee based on clear positive efficacy.

This decision follows formal interim assessment that met prespecified criteria for positive efficacy.

“Worldwide, 5 to 10 million people die each year from chronic kidney disease, and many lives are severely disrupted by dialysis treatment,” William Herrington, a clinician scientist at Oxford Population Health, said in a statement. "We studied a wide range of patients with declining kidney function with the aim of delaying the need for dialysis and avoiding heart disease in as many of them as possible.”

EMPA-KIDNEY is the largest SGLT2 inhibitor trial to date to evaluate the efficacy and safety of empagliflozin in adults with CKD who are frequently seen in clinical practice and were underrepresented in previous SGLT2 inhibitor trials.

The trial included individuals with mildly to severely reduced eGFR, patients with increased and normal levels of albumin, those with and without diabetes, and those with CKD attributable to a wide range of underlying causes.

EMPA-KIDNEY is a large, double-blind, placebo-controlled, randomized trial that included more than 6600 individuals with CKD and is being analyzed, conducted, and reported by the MRC Population Health Research Unit at the University of Oxford.

The primary endpoint of the trial is a composite of kidney disease progression or cardiovascular death. Kidney disease progression is 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 at least 40% in eGFR from randomization.

Additionally, the key secondary outcomes included cardiovascular death or all-cause hospitalization, all-cause mortality, or hospitalization for heart failure.

In March 2020, the FDA granted Fast Track designation to the clinical investigation of empagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD.

"People with kidney disease are at risk for both worsening kidney function and heart problems, making the availability of more treatment options and relevant education critical," Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development and Medical Affairs in Cardio-Metabolism & Respiratory Medicine at Boehringer Ingelheim, said in the statement.

The company plans on presenting the full results from the trial at an upcoming medical congress.

Kidney disease is a global public health issue, affecting about 37 million individuals in the United States, according to the statement.

CKD doubles an individual’s risk for hospitalization and is a leading cause of death.

CKD is also closely linked with several cardiovascular and metabolic diseases, with 37% of individuals having diabetes, 32% of adults with high blood pressure, and 18% of adults with obesity also having CKD, according to the statement.

Reference

Jardiance phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease. Lilly. News release. March 16, 2022. Accessed March 16, 2022. https://investor.lilly.com/news-releases/news-release-details/jardiancer-phase-iii-empa-kidney-trial-will-stop-early-due-clear