Effect of Pyridorin in Patients With Diabetic Nephropathy - Full Text View

Sponsor:	BioStratum
Information provided by:	BioStratum
ClinicalTrials.gov Identifier:	NCT00320021

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320021

Sponsors and Collaborators

BioStratum

Investigators

Study Director:

Thorsten P Degenhardt, Ph.D.

BioStratum, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00320021 History of Changes
Other Study ID Numbers:	PYR-205/207, PYR-205, PYR-207
Study First Received:	April 27, 2006
Last Updated:	April 27, 2006
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; South Africa: Medicines Control Council

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012