New academic collaboration to investigate effect of Jardiance in relation to progression of CKD
Boehringer Ingelheim and Eli Lilly and Company announced an academic collaboration with the University of Oxford to investigate the effects of Jardiance on the progression of kidney disease in adults with established chronic kidney disease with and without diabetes.
EMPA-Kidney will be independently conducted, analyzed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford, which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit, in partnership with the Duke Clinical Research Institute.
According to a company press release, the study is based on insights previously obtained from the EMPA-Reg Outcome trial. The trial investigated the effect of Jardiance, when added to the standard of care, on cardiovascular outcomes in adults with type 2 diabetes and established cardiovascular disease compared with placebo. About one-third of patients in the trial had 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 disease. The aim of EMPA-Kidney is to help further understanding of these data.
“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,” Jennifer Green, MD, endocrinologist and associate professor of medicine at the Duke Clinical Research Institute, which is responsible for U.S. trial operations, said in the release. “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, a multinational randomized, double-blind, placebo-controlled clinical trial, 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 Jardiance on time to clinically relevant kidney disease progression or cardiovascular death.
“Boehringer Ingelheim and Lilly are committed to exploring how Jardiance can potentially fill gaps where unmet treatment needs exist,” Thomas Seck, MD, vice president of clinical development and medical affairs – primary care for Boehringer Ingelheim Pharmaceuticals Inc., said in the press release. “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.”
Disclosure: Boehringer Ingelheim and Lilly will provide the funding for the study.