Diabetic Nephropathy
Conditions
Keywords
Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine
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.
Interventions
Sponsors
BioStratum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Serum Creatinine from baseline to week 26 | — |
Outcome results
None listed