- EMPA-KIDNEY is the largest and most inclusive SGLT2 inhibitor trial in chronic kidney disease to date
- The trial’s Independent Data Monitoring Committee recommended that the trial be stopped early due to evidence that the trial treatment is more effective than the placebo
- Detailed results will be presented later this year.
The EMPA-KIDNEY trial will stop early based on a recommendation from the trial’s Independent Data Monitoring Committee.
EMPA-KIDNEY is testing whether taking empagliflozin, a medicine normally used to treat type 2 diabetes, prevents worsening of kidney disease in people with chronic kidney disease (CKD). It will also find out whether empagliflozin helps to prevent deaths from heart disease or hospitalisation because of heart failure.
Previous clinical trials have shown that drugs like empagliflozin, called sodium-glucose co-transporter-2 (SGLT-2) inhibitors, help reduce the risk of kidney disease becoming worse in certain patients. EMPA-KIDNEY is the largest SGLT2 inhibitor trial in CKD to date, and includes a broad spectrum of adults with CKD including 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.
Many of these patients have been under-represented in previous trials.
About one third of CKD cases are attributable to metabolic conditions such as diabetes, obesity, and hypertension. The majority of deaths among people with CKD occur as a result of cardiovascular complications. When kidney disease worsens, affected individuals may have to undergo kidney replacement treatments, such as regular dialysis or kidney transplantation.
‘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 at 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.’
The decision to stop the trial early followed a planned assessment by the Independent Data Monitoring Committee which showed that empagliflozin was more effective than the control. Detailed trial results will show whether the treatment is beneficial to specific groups of patients and if there are any concerns about side effects.
Read the full press release from the Medical Research Council Population Health Research Unit at the University of Oxford, Boehringer Ingelheim, and Eli Lilly and Company (NYSE: LLY).