A physician-initiated double-blind, randomised, placebo-controlled, phase 2 study evaluating the efficacy and safety of inhibition of NADPH oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excretion: Protocol and statistical considerations
Anne T Reutens, Karin Jandeleit-Dahm, Merlin Thomas, Agus Salim, Alysha M De Livera, Leon A Bach, Peter G Colman, Timothy ME Davis, Elif Ekinci, Greg Fulcher, Peter Shane Hamblin, Mark A Kotowicz, Richard J MacIsaac, Claire Morbey, David Simmons, Georgia Soldatos, Gary Wittert, Ted Wu, Mark E Cooper, Jonathan E Shaw
Contemporary Clinical Trials | ELSEVIER SCIENCE INC | Published : 2020
PURPOSE: Kidney disease caused by type 1 diabetes can progress to end stage renal disease and can increase mortality risk. Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (Nox) plays a major role in producing oxidative stress in the kidney in diabetes, and its activity is attenuated by GKT137831, an oral Nox inhibitor with predominant inhibitory action on Nox-1 and Nox - 4. Previous studies have demonstrated renoprotective effects with GKT137831 in various experimental models of type 1 diabetes-related kidney disease. This study will evaluate the effect of GKT137831 in treating clinical diabetic kidney disease. DESIGN: This is a multi-center, randomized, placebo-controlled trial,..View full abstract
This study is an investigator-initiated trial funded by the Juvenile Diabetes Research Fund (JDRF) Australia, the recipient of the Australian Research Council Special Research Initiative in Type 1 Juvenile Diabetes, and by the Baker Heart and Diabetes Institute. Study drug is provided by Genkyotex S.A. (France). The Sponsor is the Baker Heart and Diabetes Institute and the study was designed by the members of the steering committee at the Institute and Monash University.