Effect of Pyridorin in Patients With Diabetic Nephropathy

The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1
Hemoglobin A1C <=12% at week -2
Patients with diagnosis of diabetic nephropathy as defined by

Serum Creatinine <=2.0 mg/dL at weeks -2 and -1
Urinary albumin excretion >=300 mg/24 hours at week -2
Diagnosis of diabetic retinopathy
Creatinine clearance >=40 mL/min at weeks -2 and -1
Voluntary written consent to participate in this study

Exclusion criteria

History of allergic or adverse response to any B vitamin
History of major cardiovascular or cerebrovascular events
History of cancer except adequately treated basal or squamous cell carcinoma of the skin
History of diabetic ketoacidosis

Treatment and study plan

Pyridorin (pyridoxamine dihydrochloride)

Drug

Sponsors and collaborators

Lead sponsor

BioStratum

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes

Important dates

Study start: 2001
Study completion: 2003
First posted: Apr 27, 2006
Registry last updated: Apr 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed