A phase 3 clinical trial, EMPA-KIDNEY, met its primary endpoint showing a significant kidney and cardiovascular benefit for adults living with chronic kidney disease (CKD).
When treated with Jardiance (empagliflozin), the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% versus placebo.
The results were announced today during the American Society of Nephrology’s Kidney Week 2022 by the Medical Research Council Population Health Research Unit at the University of Oxford. This is where EMPA-KIDNEY was designed, conducted and analyzed in a scientific collaboration with Boehringer Ingelheim and Eli Lilly and Company. The results were also published simultaneously in The New England Journal of Medicine.
EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to demonstrate a significant reduction in all-cause hospitalizations versus placebo, one of the pre-specified key secondary confirmatory endpoints. CKD doubles a person’s risk for hospitalization and is a leading cause of death globally. Hospitalizations account for 35%-55% of total healthcare costs for people with CKD in the U.S.
The overall safety data was generally consistent with previous findings, confirming the well-established safety profile of Jardiance.
William Herrington, EMPA-KIDNEY co-principal investigator, said: “We know that there is an urgent need for new therapies proven to delay CKD progression which can lead to the need for dialysis or transplantation. Today’s results demonstrate that Jardiance may benefit adults at risk of progression, including those with or without diabetes, and across a wide range of kidney function.
“By reducing the risk of kidney disease progression or cardiovascular death, Jardiance has the potential to positively impact healthcare systems worldwide.”
Chronic kidney disease
“The design of the EMPA-KIDNEY trial included a wider range of patients than ever before,” said Professor Richard Haynes, co-principal investigator. Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine. Today’s positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis.”
EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial to date. It included 6,609 participants across a wide range of underlying causes, many with co-morbidities across the spectrum of cardiovascular, kidney or metabolic conditions. The trial assessed both kidney and cardiovascular outcomes in people across the spectrum of CKD severity.
“The Boehringer Ingelheim and Lilly Alliance is incredibly proud that EMPA-KIDNEY has provided another pivotal moment for Jardiance,” said Carinne Brouillon, head of Human Pharma and member of the Board of Managing Directors, Boehringer Ingelheim. Today’s data adds to the body of evidence from our clinical program which includes more than 700,000 adults with cardiovascular, kidney and metabolic conditions. EMPA-KIDNEY reinforces the potential role of Jardiance in changing the way these interconnected conditions may be managed.”
Reductions in other key secondary endpoints of hospitalization for heart failure or cardiovascular death or all-cause death were not statistically significant, however the power to detect this was limited by the number of events observed. Reduction in the risk of these endpoints is consistent with the totality of the evidence from other trials which have shown statistical significance of these outcomes.
Jeff Emmick, vice president, product development, Lilly, said: “Today’s EMPA-KIDNEY trial results will be welcomed by people living with CKD and the medical community. We are also encouraged by the risk reduction for hospitalization after just two years, as this finding is in line with the significant reductions seen in prior Jardiance cardiovascular outcomes trials. The Alliance looks forward to discussing plans for marketing authorization for CKD with regulators worldwide in due course.”