EMPA-KIDNEY will study the effects of empagliflozin in CKD patients with and without diabetes.
The DCRI will partner with the University of Oxford to investigate the effects of empagliflozin (sold under the brand name Jardiance) on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease. EMPA-KIDNEY will be conducted by the Medical Research Council Population Health Research Unit at the University of Oxford, in partnership with the DCRI. Boehringer Ingelheim and Eli Lilly and Company will provide the funding for the study.
The plan to conduct a dedicated outcomes study in adults with chronic kidney disease is based on insights previously obtained from the EMPA-REG OUTCOME trial. That landmark trial investigated the effect of empagliflozin, when added to the standard of care, on cardiovascular outcomes in adults with type 2 diabetes and established cardiovascular disease, compared with placebo. Approximately one-third of patients in the EMPA-REG OUTCOME trial also had established chronic kidney disease at baseline. A secondary exploratory endpoint of the study provided promising data relating to the reduction in the relative risk of new onset or worsening kidney disease. EMPA-KIDNEY is designed to further researchers’ understanding of these data.
Chronic kidney disease is defined as a progressive decline of kidney function over time. About two-thirds of chronic kidney disease cases are attributable to metabolic diseases such as diabetes, hypertension, and obesity. Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage renal disease. Chronic kidney disease affects approximately 15 percent of adults in the United States and treatment costs are estimated to exceed $48 billion annually. Because there are currently only few treatment options, the overarching unmet medical need for new treatment options in chronic kidney disease is evident.
“We need to explore new treatment options that can help slow the progression of chronic kidney disease, given that 30 million adults in the United States are living with this condition,” said Jennifer Green, MD, endocrinologist and associate professor of medicine at the DCRI, which is responsible for U.S. trial operations. “The EMPA-REG OUTCOME trial findings prompted us to explore further the effects of empagliflozin on the risk of new or worsening kidney disease in adults with type 2 diabetes and established cardiovascular disease. Now, EMPA-KIDNEY will examine whether empagliflozin has the potential to be a new treatment option for people with chronic kidney disease.”
EMPA-KIDNEY will include approximately 5,000 adults with established chronic kidney disease, with and without diabetes. The primary outcome of the study is to assess the effect of empagliflozin on time to clinically relevant kidney disease progression or cardiovascular death. The study will be part of the empagliflozin clinical development program, the largest clinical development program of an SGLT2 inhibitor.
“Boehringer Ingelheim and Lilly are committed to exploring how Jardiance can potentially fill gaps where unmet treatment needs exist,” said Thomas Seck, MD, vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. “Given the institution’s knowledge and history of prestigious research in chronic kidney disease, we are excited to collaborate with the University of Oxford on this initiative to help address a pressing need for people with chronic kidney disease.”
“The EMPA-KIDNEY study, which will build on results of the EMPA-REG OUTCOME trial, will continue to expand our understanding of how Jardiance can impact the lives of a broad range of people with and without diabetes,” said Jeff Emmick, MD, PhD, vice president, Product Development, Lilly Diabetes. “We look forward to this new partnership and the opportunity to follow the progress of the EMPA-KIDNEY study.”