Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/22188
Title: 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.
Austin Authors: Reutens, Anne T;Jandeleit-Dahm, Karin;Thomas, Merlin;Bach, Leon A;Colman, Peter G;Davis, Timothy M E;D'Emden, Michael;Ekinci, Elif I ;Fulcher, Greg;Hamblin, Peter Shane;Kotowicz, Mark A;MacIsaac, Richard J;Morbey, Claire;Simmons, David;Soldatos, Georgia;Wittert, Gary;Wu, Ted;Cooper, Mark E;Shaw, Jonathan E
Affiliation: Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia
Department of Medicine, Austin Health, The University of Melbourne, Heidelberg, Victoria, Australia
Department of Endocrinology, Austin Health, Heidelberg, Victoria, Australia
Diabetes & Endocrinology Centre, Sunshine Hospital, 176 Furlong Road, St Albans VIC 3021, Australia
Department of Endocrinology and Diabetes, Level 5 Centre Block, The Alfred, PO Box 315, Prahran, VIC 3181, Australia
Monash University, Department of Medicine, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia
Department of Endocrinology, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards NSW 2065, Australia
The University of Sydney NSW 2006, Australia
Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia
Department of Medicine-Western Precinct, University of Melbourne St Albans VIC 3021, Australia
Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, RMH, VIC 3050, Australia
University of Western Australia, Medical School, Fremantle Hospital, PO Box 480, Fremantle, WA 6959, Australia
Endocrinology Research Unit, Level 1, Dr James Mayne Building, Royal Brisbane & Women's Hospital, Butterfield Street, Herston, QLD 4029, Australia
Deakin University, Geelong, Victoria, Australia
Department of Endocrinology & Diabetes, Level 4 Daly Wing, St Vincent's Hospital, University of Melbourne, PO Box 2900, Fitzroy, VIC 3065, Australia
Hunter Diabetes Centre, Level 1, 41 Llewellyn Street, Merewether NSW 2291, Australia
School of Medicine, Western Sydney University, Campbelltown Hospital, Therry Rd, Campbelltown, NSW 2560, Australia
Diabetes and Vascular Medicine Unit, Monash Health, 246 Clayton Road, Clayton, VIC 3168, Australia
Adelaide Medical School, Faculty of Health and Medical Sciences; The University of Adelaide, Level 5, Adelaide Health and Medical Sciences Building, Corner of North Terrace and George Street, Adelaide, SA 5005, Australia
Diabetes Centre, Royal Prince Alfred Hospital, Level 6, Missenden Road, Camperdown, NSW 2050, Australia
Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia
Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia
Issue Date: Mar-2020
metadata.dc.date: 2019-11-16
Publication information: Contemporary clinical trials 2020; 90: 105892
Abstract: 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. This is a multi-center, randomised, placebo-controlled trial, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 200 mg BID for 48 weeks. The study will randomize 142 participants who have persistent albuminuria and estimated glomerular filtration rate (eGFR) at baseline of at least 40 ml/min/1.73m2. Difference between arms in urine albumin to creatinine ratio. Secondary outcome measures include eGFR. This study is important because it may identify a new way of halting renal disease progression in people with type 1 diabetes and albuminuria already receiving standard of care treatment.
URI: http://ahro.austin.org.au/austinjspui/handle/1/22188
DOI: 10.1016/j.cct.2019.105892
ORCID: 0000-0003-2372-395X
PubMed URL: 31740428
Type: Journal Article
Subjects: Albuminuria
Diabetic nephropathy;
NADPH oxidase
Type 1 diabetes
Appears in Collections:Journal articles

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