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2022 | HFSA

Jardiance® phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease

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OXFORD, United Kingdom and RIDGEFIELD, Conn. and INDIANAPOLIS, March 16, 2022 /PRNewswire/ -- The EMPA-KIDNEY trial, evaluating the effect of Jardiance® (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 Jardiance 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. 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.

"Worldwide 5 to 10 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."