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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00320060

Enrollment

128

Registered

2006-04-27

Start date

2001-10-31

Completion date

2003-01-31

Last updated

2006-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine

Brief summary

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.

Interventions

DRUGPyridorin (pyridoxamine dihydrochloride)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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 2. Urinary albumin excretion \>=300 mg/24 hours at week -2 3. 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026