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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Mar 2015

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At a glance

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

Most Recent Events

  • 24 Mar 2015 Status changed from planning to recruiting, based on a NephroGenex media release.
  • 24 Mar 2015 According to a media release, NephroGenex received support from the EMA on the new endpoint and the study design for their ongoing phase III trial in diabetic nephropathy. The EMA indicated that the current phase III program could support a Marketing Authorization Application for full market approval in Europe.
  • 26 Jun 2014 New trial record

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