New drug trial scheduled to combat kidney disease in type 1 diabetes

A new trial has been scheduled to test the success of a drug candidate in people with type 1 diabetes and diabetic kidney disease (DKD).
GKT831 is the lead drug candidate of French biopharmaceutical company Genkyotex. This new trial, which will be conducted in Australia and is supported by JDRF, is aiming to demonstrate GKT831 can improve renal function and reduce albuminuria, which is when there is too much protein in the urine.
Enrolment for the trial is set to begin later this year, with researchers hoping the drug can eventually be used to reduce renal complications caused by type 1 diabetes.
As part of the study, patients will receive 200mg of oral GKT831 or placebo twice daily for 48 weeks. GKT831 is a NOX 1 and 4 enzyme inhibitor which has been shown to have anti-fibrotic (lower scarring of connective tissue) effects in people with DKD.
In one of these previous studies, however, the study’s primary endpoint was not met, which was for the drug to indicate improvements in albuminuria after 12 weeks of treatment.
This new trial will primarily evaluate the effect of oral GKT831 on people with type 1 diabetes and persistent albuminuria who have received optimal standard of care. This will be accessed via improvements in patients’ urine albumin-to-creatinine ratio (UACR).
Professor Mark Cooper, Head of the Department of Diabetes at Monash University, a co-leader of the study said: “This work is a classic example of bench to bedside clinical translation. We are very excited to be commencing this study which arises in part from original research performed in our laboratories and which was initially supported by JDRF.
“We appreciate JDRF greatly assisting us in providing us with an opportunity to bring this new treatment forward for what is a major burden of T1D kidney disease.”