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

  • 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

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.”

“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 about 37 million people in the U.S. CKD is a leading cause of death globally and doubles a person’s risk for hospitalization. CKD is closely linked with several metabolic and cardiovascular diseases: 37% of adults with diabetes, 32% of adults with high blood pressure and 18% of adults with obesity also have CKD.

*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% in eGFR from randomization.

About Chronic Kidney Disease
CKD is defined as abnormalities in kidney structure or function and requires either GFR below 60 ml/min/1.73 m2 or markers of kidney damage, including albuminuria, for at least three months. CKD affects approximately 15% of adults in the U.S. CKD is present in 32% of adults with high blood pressure, 37% of adults with diabetes (known as diabetic kidney disease) and 18% of adults with obesity. CKD is a leading cause of death in the U.S. and is associated with twice the risk of hospitalization. People with CKD have reduced life expectancy, with an average loss of 25 years at advanced stages versus individuals with normal kidney function. The majority of deaths among people with CKD occur as a result of cardiovascular complications, often before they reach end stage renal disease. In 2018, Medicare spent $81 billion on care for people with CKD.

About the Medical Research Council Population Health Research Unit at the University of Oxford
The MRC PHRU at the University of Oxford, part of Oxford Population Health, improves the treatment and prevention of chronic diseases, particularly cardiovascular disease and metabolic disease (such as diabetes mellitus and chronic kidney disease), which collectively account for a large proportion of premature adult deaths and the burden of disability worldwide. MRC PHRU is led by EMPA-KIDNEY Steering Committee co-chair Professor Colin Baigent. MRC -PHRU coordinates innovative clinical trials and meta-analyses that have a major impact on health.

Prioritizing Cardio-Renal-Metabolic Care
Through research and educational initiatives, Boehringer Ingelheim and Lilly are driven to redefine care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.

The cardiovascular, renal (kidney) and metabolic systems are closely intertwined and share many of the same disease-related pathways. Dysfunction in one system may accelerate the onset of dysfunction in others, resulting in the progression of comorbid diseases such as type 2 diabetes, heart failure and chronic kidney disease.

Understanding their interconnected nature, we are working to advance treatments that can protect the organs of the cardio-renal-metabolic systems. It is only through a holistic approach to care that we can truly transform outcomes and restore the harmony between these critical systems.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

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