The phase 3 EMPA-KIDNEY clinical trial had just met prespecified criteria for positive efficacy when the study's Independent Data Monitoring Committee recommended the early halt.
EMPA-KIDNEY, the large phase 3 clinical trial assessing the use of empagliflozin (Jaridance) in adults with chronic kidney disease (CKD), has been stopped early, based on a recommendation from trial’s Independent Data Monitoring Committee. The announcement was made on March 16 in a statement from Eli Lilly and Company.
The trial, which includes more than 6600 participants, had just recently met prespecified criteria for positive efficacy during a formal interim assessment, an outcome reported by the Medical Research Council Population Health Research Unit at the University of Oxford, Eli Lilly, and drug codeveloper Boehringer Ingelheim.
Kidney disease affects approximately 37 million Americans and is a leading cause of death globally, the statement notes. CKD doubles a person's risk for hospitalization and is closely linked with several metabolic and cardiovascular diseases. For example, it is estimated that 37% of adults with diabetes, 32% of adults with hypertension, and 18% of adults with obesity also have CKD.
"Worldwide 5 to 10 million people die each year from chronic kidney disease and many lives are severely disrupted by dialysis treatment," said associate professor William Herrington, clinician scientist Oxford Population Health, honorary consultant nephrologist and EMPA-KIDNEY co-principal investigator, in the 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."
The study of empagliflozin, a sodium glucose cotransporter-2 (SGLT-2) inhibitor, is a double-blind, randomized, placebo-controlled trial, described in the Lilly statement as “the largest SGLT-2 inhibitor trial in CKD to date.” Enrolled in the trial are adults with CKD who although they are seen frequently in clinical practice have been historically underrepresented in trials of SGLT-2 inhibitors. EMPA-KIDNEY includes those with mildly to severely elevated estimated glomerular filtration rate, normal and increased albumin levels, with and without type 2 diabetes, and whose CKD has a wide range of etiologies.
The trial has as its primary endpoint a composite of kidney disease progression or cardiovascular death and key secondary outcomes include cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality. The MRC Population Health Research Unit at the University of Oxford is conducting, analyzing, and reporting findings from EMPA-KIDNEY.
The US Food and Drug Administration in March 2020 granted Fast Track designation to the investigation of emplagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD, according to the Lilly statement. The full results, it adds, will be presented at an upcoming medical meeting.