Boehringer Ingelheim and Eli Lilly are linking with Oxford University to assess the effect of SGLT2 inhibitor Jardiance on kidney disease and cardiovascular death.
The EMPA-KIDNEY trial will involve around 5,000 adults with established chronic kidney disease with and without diabetes, the primary aim being to assess the effect of the drug on time to clinically relevant kidney disease progression or cardiovascular death.
Under the academic collaboration, the study will be independently conducted, analysed 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.
Boehringer and Lilly will provide the funding for the study.
“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, endocrinologist and associate professor of medicine at the Duke Clinical Research Institute, which is responsible for US 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.”
Data from the landmark EMPA-REG OUTCOME trial showed that Jardiance cut the risk of cardiovascular death in adults with type II diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study.
Last month Boehringer and Lilly announced two new Phase III studies investigating the drug’s potential in patients with chronic heart failure.