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A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes

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Trial Profile

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Pyridoxamine (Primary)
  • Indications Diabetic nephropathies; Renal failure
  • Focus Registrational; Therapeutic Use
  • Acronyms PIONEER
  • Sponsors NephroGenex

    • Most Recent Events

    • 08 Mar 2016 Status changed from recruiting to discontinued, as reported by ClinicalTrials.gov.
    • 21 Jan 2016 According to a NephroGenex media release, an independent Data and Safety Board (DSMB) has completed the second pre-planned safety review and has recommended continuation of this trial as planned.
    • 13 May 2015 According to NephroGenex media release, the European Medicines Agency indicated that this trial may be adequate to support a Marketing Authorization Application in Europe.

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