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Pyridorin in Diabetic Nephropathy

NCT02156843 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2016-03-09

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathy
  • Diabetic Kidney Disease

Interventions

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.

Sponsors & Collaborators

  • Collaborative Study Group (CSG)

    collaborator NETWORK

  • Medpace, Inc.

    collaborator INDUSTRY

  • NephroGenex, Inc.

    lead INDUSTRY

Principal Investigators

  • Jamie Dwyer, MD · The Collaborative Study Group (CSG) [Co-Chair]

  • Julia B. Lewis, MD · The Collaborative Study Group (CSG)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • United States
  • Australia
  • Bulgaria
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Mauritius
  • Poland
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156843 on ClinicalTrials.gov