Status:
COMPLETED
Effect of Pyridorin in Patients With Diabetic Nephropathy
Lead Sponsor:
BioStratum
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 kidn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00320021
Start Date
July 1 2002
End Date
September 1 2003
Last Update
April 27 2006
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