Effect of Pyridorin in Patients With Diabetic Nephropathy

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Pyridorin (pyridoxamine dihydrochloride)

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00320060

First Posted

April 27, 2006

Last Updated

April 27, 2006

Sponsor

BioStratum

1. Study Identification

Unique Protocol Identification Number

NCT00320060

Brief Title

Effect of Pyridorin in Patients With Diabetic Nephropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2006

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 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 and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 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

128 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pyridorin (pyridoxamine dihydrochloride)

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thorsten P Degenhardt, Ph.D.

Organizational Affiliation

BioStratum, Inc.

Official's Role

Study Director

Diabetic Nephropathy

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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