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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Apr 2022

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At a glance

  • Drugs Setanaxib (Primary)
  • Indications Diabetic nephropathies; Renal fibrosis
  • Focus Therapeutic Use
  • Most Recent Events

    • 07 Jul 2021 Planned number of patients changed from 142 to 92.
    • 07 Jul 2021 Planned End Date changed from 1 Jul 2020 to 30 Jun 2022.
    • 27 Jan 2021 According to a GenKyoTex media release, to date, 29 patients have completed the full 48-week treatment and no safety signals have been identified.
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