Effect of Pyridorin in Patients With Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320021
• Other study ID #: PYR-205/207
• Secondary ID: PYR-205PYR-207
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2006
• Last updated: April 27, 2006
• Start date: July 2002
• Est. completion date: September 2003

Study information

• Verified date: April 2006
• Source: BioStratum
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Pyridorin (pyridoxamine dihydrochloride)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioStratum

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Creatinine from baseline to week 26