- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00320021
Effect of Pyridorin in Patients With Diabetic Nephropathy
April 27, 2006 updated by: BioStratum
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
80
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in Serum Creatinine from baseline to week 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Thorsten P Degenhardt, Ph.D., BioStratum, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion
September 1, 2003
Study Registration Dates
First Submitted
April 27, 2006
First Submitted That Met QC Criteria
April 27, 2006
First Posted (Estimate)
April 27, 2006
Study Record Updates
Last Update Posted (Estimate)
April 27, 2006
Last Update Submitted That Met QC Criteria
April 27, 2006
Last Verified
April 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PYR-205/207
- PYR-205
- PYR-207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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