NCT00320021CompletedPhase 2
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
BioStratum0 sites80 target enrollmentStarted: July 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Change in Serum Creatinine from baseline to week 26
Study Overview
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 kidney disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Serum Creatinine from baseline to week 26
Secondary Outcomes
No secondary outcomes reported
Investigators
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