Trial | NCT00320060  Report issue

Title

Effect of Pyridorin in Patients With Diabetic Nephropathy
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pyridoxamine ...

  • Study Participants

    128
The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.
Study Started
Oct 31
2001
Study Completion
Jan 31
2003
Last Update
Apr 27
2006
Estimate

Drug Pyridorin (pyridoxamine dihydrochloride)

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

Serum Creatinine <=2.0 mg/dL at weeks -2 and -1
Urinary albumin excretion >=300 mg/24 hours at week -2
Diagnosis of diabetic retinopathy
Creatinine clearance >=40 mL/min at weeks -2 and -1
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
No Results Posted