CClinicalTrials.gg
Sign In
CompletedNCT00320060Updated Apr 27, 2006

Effect of Pyridorin in Patients With Diabetic Nephropathy

A Phase 2 interventional study of Pyridorin (pyridoxamine dihydrochloride) in Diabetic Nephropathy, sponsored by BioStratum. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-04-27.

Sponsored by BioStratum · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Nephropathy

Keywords

  • Diabetic nephropathy
  • Advanced Glycation Endproduct Inhibitor
  • Pyridorin
  • Pyridoxamine
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 128 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

BioStratum is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
    2. Urinary albumin excretion >=300 mg/24 hours at week -2
    3. Diagnosis of diabetic retinopathy
  • Creatinine clearance >=40 mL/min at weeks -2 and -1
  • Voluntary written consent to participate in this study

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
128 participants

Interventions

  • DrugPyridorin (pyridoxamine dihydrochloride)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00320060
Lead sponsor
BioStratum
First posted
Apr 27, 2006
Start date
Oct 2001
Completion
Jan 2003
Last update
Apr 27, 2006

Study contacts

Thorsten P Degenhardt, Ph.D.
study director · BioStratum, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Kidney Diseases→

Other studies from this sponsor

BioStratum

Start the discussion