Potential breakthrough treatment for chronic kidney disease and diabetes
The CREDENCE trial, investigating a breakthrough treatment for chronic kidney disease and type 2 diabetes, has been ended early after benefit was demonstrated at an interim analysis.
The study, being led by The George Institute for Global Health, could herald the first new drug therapy in more than 15 years for slowing down the progression of chronic kidney disease (CKD) in patients with type 2 diabetes.
Professor Vlado Perkovic, Executive Director of The George Institute, Australia and study lead, said the results were incredibly important and could be transformative given nearly half of people with type 2 diabetes develop CKD.
“This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago,” Perkovic said. “We have accepted the advice of the Independent Data Monitoring Committee to stop the CREDENCE trial early due to demonstration of efficacy, and look forward to sharing the findings as soon as possible," said Professor Perkovic who is also Professor of Medicine at UNSW Sydney.
The trial of 4400 patients had been investigating the benefits and safety of canaglifozin (INVOKANA) but was stopped early after achieving pre-specified efficacy criteria.
The decision is based on a recommendation from the study's Independent Data Monitoring Committee that met to review the data during a planned interim analysis. This recommendation was based on demonstration of efficacy, as the trial had achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular death, when used in addition to standard of care.
Worldwide, 160 million patients with type 2 diabetes are at risk for developing chronic kidney disease.
The full data from the trial will be presented at an upcoming medical conference and published in the near future.