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Effect of Pyridorin in Patients With Diabetic Nephropathy

NCT ID: NCT00320021

Last Updated: 2006-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Nephropathy

Keywords

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Diabetic nephropathy Advanced Glycation Endproduct Inhibitor Pyridorin Pyridoxamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pyridorin (pyridoxamine dihydrochloride)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioStratum

INDUSTRY

Sponsor Role lead

Principal Investigators

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Thorsten P Degenhardt, Ph.D.

Role: STUDY_DIRECTOR

BioStratum, Inc.

Other Identifiers

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PYR-205

Identifier Type: -

Identifier Source: secondary_id

PYR-207

Identifier Type: -

Identifier Source: secondary_id

PYR-205/207

Identifier Type: -

Identifier Source: org_study_id