Boehringer Ingelheim, Lilly, University of Oxford to study empagliflozin in chronic kidney disease

EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes.

The study will be independently conducted, analysed and reported by the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU), which is based in the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU).

Boehringer Ingelheim and Eli Lilly and Company will provide the funding for the study.

The plan to conduct a dedicated outcomes study in people with chronic kidney disease is based on insights previously obtained from the EMPA-REG OUTCOME trial. This landmark trial investigated the effect of empagliflozin, when added to the standard of care, on cardiovascular outcomes in people 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 will help to further understand this data.

University of Oxford, UK MRC PHRU director Colin Baigent said: “The data from the EMPA-REG OUTCOME trial indicate that empagliflozin may have the potential to slow progression of kidney disease and to lower cardiovascular risk among people with chronic kidney disease.

“Chronic kidney disease is estimated to affect more than 200 million individuals worldwide and many of these patients are at substantial risk of progressing to end-stage kidney disease. In addition, people with chronic kidney disease are at increased risk of premature death from cardiovascular causes.

“In light of the high medical need in this area, we are excited to be leading the EMPA-KIDNEY study to find out whether empagliflozin could become a new treatment option to improve the lives of people with chronic kidney disease.”

EMPA-KIDNEY will include approximately 5,000 people 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 programme, the largest clinical development programme of an SGLT2 inhibitor.

Boehringer Ingelheim therapeutic area cardiometabolism senior vice president Georg van Husen said: “We are delighted to partner with such a prestigious academic institution as Oxford University.

“The scientists at Oxford University have a proven track record in conducting innovative and paradigm changing clinical trials in patients with chronic kidney disease.

“We share a common interest and commitment to better understand and improve the treatment of chronic kidney disease, and are excited to further explore the potential of empagliflozin in new disease areas.”

Lilly Diabetes product development vice president Jeff Emmick said: “The EMPA-KIDNEY study, which will build on results of the EMPA-REG OUTCOME trial, will continue to expand our understanding of how empagliflozin can impact the lives of a broad range of people with and without diabetes.

“We look forward to this new partnership, and the opportunity to follow the progress of the EMPA-KIDNEY study.”

Source: Company Press Release.