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Effect of Pyridorin in Patients With Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320021
First Posted: April 27, 2006
Last Update Posted: April 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioStratum
  Purpose
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.

Condition Intervention Phase
Diabetic Nephropathy Drug: Pyridorin (pyridoxamine dihydrochloride) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by BioStratum:

Primary Outcome Measures:
  • Change in Serum Creatinine from baseline to week 26

Estimated Enrollment: 80
Study Start Date: July 2002
Estimated Study Completion Date: September 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    1. 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)
    2. Urinary albumin excretion >=300 mg/24 hours at week -2
    3. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320021


Sponsors and Collaborators
BioStratum
Investigators
Study Director: Thorsten P Degenhardt, Ph.D. BioStratum, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00320021     History of Changes
Other Study ID Numbers: PYR-205/207
PYR-205
PYR-207
First Submitted: April 27, 2006
First Posted: April 27, 2006
Last Update Posted: April 27, 2006
Last Verified: April 2006

Keywords provided by BioStratum:
Diabetic nephropathy
Advanced Glycation Endproduct Inhibitor
Pyridorin
Pyridoxamine

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pyridoxamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs