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https://repository.monashhealth.org/monashhealthjspui/handle/1/29385| 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. | Authors: | Reutens A.T.;Colman P.G.;Davis T.M.E.;Ekinci E.I.;Fulcher G.;Hamblin P.S.;Kotowicz M.A.;MacIsaac R.J.;Morbey C.;Simmons D.;Soldatos G. ;Wittert G.;Wu T.;Cooper M.E.;Shaw J.E.;De Livera A.M.;Bach L.A.;Salim A.;Thomas M.;Jandeleit-Dahm K. | Monash Health Department(s): | Diabetes and Vascular Medicine | Institution: | (Reutens, Salim, De Livera, Shaw) Baker Heart and Diabetes Institute, Level 4, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia (Jandeleit-Dahm, Thomas, Cooper) Monash University, Department of Diabetes, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia (Bach) Department of Endocrinology and Diabetes, Level 5 Centre Block, The Alfred, PO Box 315, Prahran, VIC 3181, Australia (Bach) Monash University, Department of Medicine, Central Clinical School, Level 5, Alfred Centre, 99 Commercial Road, Melbourne, VIC 3004, Australia (Colman) Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, RMH VIC 3050, Australia (Davis) University of Western Australia, Medical School, Fremantle Hospital, PO Box 480, Fremantle, WA 6959, Australia (Ekinci) Department of Medicine, The University of Melbourne and Department of Endocrinology, Austin Health, Heidelberg Repatriation Hospital, Department of Medicine, Boronia Building, Level 1, 300 Waterdale Rd, Heidelberg, VIC 3081, Australia (Fulcher) Department of Endocrinology, Level 3, Acute Services Building, Royal North Shore Hospital, St Leonards, NSW 2065, Australia (Hamblin) Diabetes & Endocrinology Centre, Sunshine Hospital, 176 Furlong Road, St Albans, VIC 3021, Australia (Hamblin) Department of Medicine-Western Precinct, University of Melbourne, St Albans, VIC 3021, Australia (Kotowicz) Deakin University, Geelong, VIC, Australia (MacIsaac) Department of Endocrinology & Diabetes, Level 4 Daly Wing, St Vincent's Hospital, University of Melbourne, PO Box 2900, Fitzroy, VIC 3065, Australia (Morbey) Hunter Diabetes Centre, Level 1, 41 Llewellyn Street, Merewether, NSW 2291, Australia (Simmons) School of Medicine, Western Sydney University, Campbelltown Hospital, Therry Rd, Campbelltown, NSW 2560, Australia (Soldatos) Diabetes and Vascular Medicine Unit, Monash Health, 246 Clayton Road, Clayton, VIC 3168, Australia (Wittert) 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 (Wu) Diabetes Centre, Level 6, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia (Fulcher, Wu) The University of Sydney NSW 2006, Australia | Issue Date: | 7-Feb-2020 | Copyright year: | 2020 | Publisher: | Elsevier Inc. (E-mail: usjcs@elsevier.com) | Place of publication: | United States | Publication information: | Contemporary Clinical Trials. 90 (no pagination), 2020. Article Number: 105892. Date of Publication: March 2020. | Journal: | Contemporary Clinical Trials | 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 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(s): This is a multi-center, randomized, placebo-controlled trial, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 400 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. Primary outcome measures: Difference between arms in urine albumin to creatinine ratio. Secondary outcome measures include eGFR. Conclusion(s): 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.Copyright © 2019 | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/j.cct.2019.105892 | PubMed URL: | 31740428 [http://www.ncbi.nlm.nih.gov/pubmed/?term=31740428] | ISSN: | 1551-7144 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/29385 | Type: | Article | Subjects: | randomized controlled trial risk assessment treatment duration trough concentration unspecified side effect/si [Side Effect] urinary excretion urinary tract infection/dt [Drug Therapy] *albumin/ec [Endogenous Compound] alfentanil/cb [Drug Combination] angiotensin receptor antagonist/dt [Drug Therapy] antibiotic agent/dt [Drug Therapy] astemizole/cb [Drug Combination] cisapride/cb [Drug Combination] clarithromycin/cb [Drug Combination] conivaptan/cb [Drug Combination] creatinine/ec [Endogenous Compound] cyclosporine/cb [Drug Combination] dihydroergotamine/cb [Drug Combination] dipeptidyl carboxypeptidase inhibitor/dt [Drug Therapy] ergotamine/cb [Drug Combination] fentanyl/cb [Drug Combination] indinavir plus ritonavir/cb [Drug Combination] itraconazole/cb [Drug Combination] ketoconazole/cb [Drug Combination] lopinavir plus ritonavir/cb [Drug Combination] pimozide/cb [Drug Combination] placebo quinidine/cb [Drug Combination] rapamycin/cb [Drug Combination] *reduced nicotinamide adenine dinucleotide phosphate oxidase/ec [Endogenous Compound] ritonavir/cb [Drug Combination] *setanaxib/ae [Adverse Drug Reaction] *setanaxib/ct [Clinical Trial] *setanaxib/cb [Drug Combination] *setanaxib/cm [Drug Comparison] *setanaxib/cr [Drug Concentration] *setanaxib/dt [Drug Therapy] *setanaxib/pd [Pharmacology] tacrolimus/cb [Drug Combination] telaprevir/cb [Drug Combination] terfenadine/cb [Drug Combination] voriconazole/cb [Drug Combination] *setanaxib/pk [Pharmacokinetics] clinical evaluation clinical protocol adult aged *albuminuria/dt [Drug Therapy] animal experiment antibiotic therapy article controlled study creatinine blood level creatinine urine level *diabetic nephropathy/dt [Drug Therapy] diabetic patient double blind procedure drug blood level drug efficacy drug safety drug withdrawal estimated glomerular filtration rate female human *insulin dependent diabetes mellitus/dt [Drug Therapy] major clinical study male microalbuminuria mouse multicenter study nonhuman outcome assessment patient compliance phase 2 clinical trial physician trough concentration unspecified urinary excretion urinary tract infection albumin alfentanil angiotensin receptor antagonist antibiotic agent astemizole cisapride clarithromycin conivaptan creatinine cyclosporine dihydroergotamine dipeptidyl carboxypeptidase inhibitor ergotamine fentanyl indinavir plus ritonavir itraconazole ketoconazole lopinavir plus ritonavir pimozide quinidine rapamycin reduced nicotinamide adenine dinucleotide phosphate oxidase ritonavir setanaxib setanaxib/ct tacrolimus telaprevir terfenadine voriconazole setanaxib clinical protocol aged albuminuria antibiotic therapy creatinine blood level creatinine urine level diabetic nephropathy diabetic patient drug blood level drug efficacy drug safety drug withdrawal estimated glomerular filtration rate insulin dependent diabetes mellitus microalbuminuria patient compliance phase 2 physician creatinine urine level *diabetic nephropathy / *drug therapy diabetic patient double blind procedure drug blood level drug efficacy drug safety drug withdrawal estimated glomerular filtration rate female human *insulin dependent diabetes mellitus / *drug therapy major clinical study male microalbuminuria mouse multicenter study nonhuman outcome assessment patient compliance phase 2 clinical trial physician randomized controlled trial risk assessment aged trough concentration unspecified side effect / side effect urinary excretion urinary tract infection / drug therapy adult treatment duration *albuminuria / *drug therapy animal experiment antibiotic therapy Article clinical evaluation clinical protocol controlled study creatinine blood level |
Type of Clinical Study or Trial: | Randomised controlled trial |
| Appears in Collections: | Articles |
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