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Safety and Efficacy Study of Pyridorin in Patients With Nephropathy Due to Type 2 Diabetes

NCT00734253 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2015-10-28

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of two different doses of Pyridorin (150 mg and 300 mg)compared to placebo in retarding the progression of diabetic nephropathy. This will be assessed by measuring the change in serum creatinine and other biomarkers of kidney disease during the course of the 1-year study.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

Pyridoxamine Dihydrochloride

150 mg capsules taken orally twice a day for 1-year.

DRUG

Pyridoxamine Dihydrochloride

300 mg capsules taken twice a day for 1-year.

DRUG

Placebo

Placebo capsules taken twice a day for 1-year

Sponsors & Collaborators

  • Collaborative Study Group (CSG)

    collaborator NETWORK

  • Medpace, Inc.

    collaborator INDUSTRY

  • NephroGenex, Inc.

    lead INDUSTRY

Principal Investigators

  • Edmund J. Lewis, MD · Collaborative Study Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

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 NCT00734253 on ClinicalTrials.gov