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OpenTrials
Completed

NCT Number: NCT00320021

Effect of Pyridorin in Patients With Diabetic Nephropathy

The primary objective of the study is to evaluate the safety, tolerability and efficacy of Pyridorin (pyridoxamine dihydrochloride) up to 250 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 (PYR-205) Serum Creatinine >2.0 mg/dL but <=3.5 mg/dL at weeks -2 and -1 (PYR-207)
  • Urinary albumin excretion >=300 mg/24 hours at week -2
  • No other known or suspected etiology for nephropathy
  • 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
  • Autoimmune diseases
  • History of significant peripheral neuropathy

Treatment and study plan

Pyridorin (pyridoxamine dihydrochloride)

Drug

Primary outcomes

  1. Change in Serum Creatinine from baseline to week 26

Sponsors and collaborators

Lead sponsor

BioStratum

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Escalating Dose, Pilot Study to Evaluate the Safety, Tolerability and Biologic Activity of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes

Important dates

Study start
2002
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.

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