- The Independent Data Monitoring Committee recommended that the EMPA-KIDNEY trial be stopped early, following a formal interim assessment
- EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease to date
- Detailed results are expected to be presented later this year
Dubai, United Arab Emirates: The EMPA-KIDNEY trial, evaluating the effect of empagliflozin in adults with chronic kidney disease (CKD), will stop early based on a recommendation from the trial’s Independent Data Monitoring Committee. This follows a formal interim assessment that met prespecified criteria for positive efficacy, announced the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim, and Eli Lilly and Company (NYSE: LLY).
As the largest SGLT2 inhibitor trial in CKD to date, EMPA-KIDNEY is evaluating the efficacy and safety of empagliflozin in adults with CKD who are frequently seen in clinical practice but who have been under-represented in previous SGLT2 inhibitor trials, therefore addressing a critical unmet need. The trial includes people:
- with mildly to severely reduced eGFR (a measure of kidney function);
- with normal and increased levels of albumin (a type of protein present in the urine);
- with and without diabetes;
- with CKD attributable to a wide range of underlying causes.
EMPA-KIDNEY is a large, double-blind, randomized, placebo-controlled, academic-led trial, including more than 6,600 adults with CKD.2 The trial is being conducted, analyzed, and reported by the MRC Population Health Research Unit at the University of Oxford. The primary endpoint of the trial is a composite of kidney disease progression* or cardiovascular death. Key secondary outcomes include cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality.2
“Worldwide five to ten million people die each year from chronic kidney disease and many lives are severely disrupted by dialysis treatment,” said Associate Professor William Herrington, Clinician Scientist Oxford Population Health, Honorary Consultant Nephrologist, and EMPA-KIDNEY co-Principal Investigator. “We studied a wide range of patients with declining kidney function with the aim of delaying the need for dialysis and avoiding heart disease in as many of them as possible.”
“We are thrilled that the trial has shown that empagliflozin is beneficial among the patients studied in EMPA-KIDNEY,” said Professor Richard Haynes, co-Principal Investigator. “We are very grateful to all of the participants who have made this trial possible and look forward to sharing detailed trial results later this year.”
Kidney disease is a global public health issue, affecting nearly 850 million people, which is more than one in ten adults. CKD is a leading cause of death globally and doubles a person’s risk for hospitalization. Additionally, CKD is closely linked with several metabolic and cardiovascular diseases such as diabetes, high blood pressure, and obesity.
“At Boehringer Ingelheim, our goal is to create innovation to make breakthrough therapies that improve the lives of patients. There are millions of patients across the globe living with chronic kidney disease who are at risk of worsening kidney function and heart problems. The clear evidence of the positive efficacy of empagliflozin in adults with chronic kidney disease is a significant milestone. The early stop of EMPA-KIDNEY trial has accelerated our timelines, helping us deliver a potential treatment option for people with chronic kidney disease earlier than expected,” said Mohammed Al-Tawil, Regional Managing Director and Head of Human Pharma at Boehringer Ingelheim India, Middle East, Turkey and Africa (‘IMETA’).
Full results from the EMPA-KIDNEY trial will be presented at an upcoming medical congress.
EMPA-KIDNEY follows the landmark EMPA-REG OUTCOME® and EMPEROR trials, all of which demonstrated cardio-renal benefits of empagliflozin. EMPA-REG OUTCOME was the first SGLT2 inhibitor cardiovascular outcome trial to show benefits in both cardiovascular and kidney† outcomes in type 2 diabetes patients with established cardiovascular disease on standard of care.10 Additionally, sub-analysis from the EMPEROR trials showed cardio-renal benefits with empagliflozin in adults with chronic heart failure, regardless of ejection fraction.
The EMPA-KIDNEY trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
*Defined as end-stage kidney disease (the initiation of maintenance dialysis or receipt of a kidney transplant), a sustained decline in eGFR to below 10 mL/min/1.73 m2, renal death or a sustained decline of at least 40 percent in eGFR from randomization).
Secondary pre-specified exploratory endpoint: incident or worsening nephropathy, relative risk reduction of 39 percent. Defined as progression to macroalbuminuria, doubling of serum creatinine (accompanied by eGFR [MDRD] ≤45 mL/min/1.73 m2), initiation of renal replacement therapy or death from kidney disease.
eGFR, estimated glomerular filtration rate; MDRD, Modification of Diet in Renal Disease.
