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
Phase of Trial: Phase III
Latest Information Update: 28 Oct 2016
At a glance
- Drugs Pyridoxamine (Primary)
- Indications Diabetic nephropathies; Renal failure
- Focus Registrational; Therapeutic Use
- Acronyms PIONEER
- Sponsors NephroGenex
- 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.