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Effect of Pyridorin in Patients With Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pyridorin (pyridoxamine dihydrochloride)
Sponsored by
BioStratum
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in Serum Creatinine from baseline to week 26

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2006
    Last Updated
    April 27, 2006
    Sponsor
    BioStratum
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00320021
    Brief Title
    Effect of Pyridorin in Patients With Diabetic Nephropathy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    BioStratum

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Nephropathy
    Keywords
    Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    80 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pyridorin (pyridoxamine dihydrochloride)
    Primary Outcome Measure Information:
    Title
    Change in Serum Creatinine from baseline to week 26

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 (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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thorsten P Degenhardt, Ph.D.
    Organizational Affiliation
    BioStratum, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Pyridorin in Patients With Diabetic Nephropathy

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