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.
Contemp Clin Trials
; 90: 105892, 2020 03.
Article
em En
| MEDLINE
| ID: mdl-31740428
ABSTRACT
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 Noxâ¯-â¯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, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 400â¯mg BID for 48â¯weeks. The study will randomize 142 participants who have persistent albuminuria and estimated glomerular filtration rate (eGFR) at baseline of at least 40â¯ml/min/1.73m2. PRIMARY OUTCOMEMEASURES:
Difference between arms in urine albumin to creatinine ratio. Secondary outcome measures include eGFR.CONCLUSION:
This study is important because it may identify a new way of slowing renal disease progression in people with type 1 diabetes and albuminuria already receiving standard of care treatment.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Piridonas
/
NADPH Oxidases
/
Pirazolonas
/
Diabetes Mellitus Tipo 1
/
Nefropatias Diabéticas
/
Albuminúria
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article