NCT00320021

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

April 27, 2006

Status Verified

April 1, 2006

First QC Date

April 27, 2006

Last Update Submit

April 27, 2006

Conditions

Diabetic Nephropathy

Keywords

Diabetic nephropathyAdvanced Glycation Endproduct InhibitorPyridorinPyridoxamine

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Creatinine from baseline to week 26

Interventions

Pyridorin (pyridoxamine dihydrochloride)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

pyridoxamine dihydrochloride

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Thorsten P Degenhardt, Ph.D.

    BioStratum, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

July 1, 2002

Study Completion

September 1, 2003

Last Updated

April 27, 2006

Record last verified: 2006-04