NCT02156843

Pyridorin in Diabetic Nephropathy

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 (PIONEER)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: NephroGenex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.

Detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase 3 study to evaluate the safety and efficacy of Pyridorin 300 mg BID (twice daily, every 12 hours) in subjects with nephropathy due to type 2 diabetes mellitus. In this study, nephropathy is defined as a Serum Creatinine (SCr) \>= 1.3 (≥1.25) mg/dL (111 umol/L) for female and \>=1.5 (≥1.45) mg/dL (128 umol/L) for male subjects and a 24-hour urine collection protein/creatinine ration (PCR) \>=1200 mg/g (136 mg/mmol), and if applicable for PS Phase, at Visit 1S or 1.1S a 24-urine collection PCR ≥600 mg/g (68 mg/mmol). Subjects must have a baseline SCr \< 3.0 mg/dL (265 umol/L) and must be on previously established standard of care at screening.

Conditions

• Diabetic Nephropathy
• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	Pyridorin	300 mg BID (twice daily, every 12 hours), oral capsule taken until end stage renal disease or death occurs, or the study is terminated by the sponsor.
DRUG	Placebo	Placebo excipients without the active drug, oral capsule taken BID (twice daily, every 12 hours), until end stage renal disease or death occurs, or the study is terminated by the sponsor.

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2014-06-05
• Last updated: 2016-03-09

Locations

137 sites across 12 countries: United States, Australia, Bulgaria, France, Germany, Hong Kong, Hungary, Israel, Mauritius, Poland, Puerto Rico, Spain