A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria

This study has been withdrawn prior to enrollment.
(Drug unavailable)
Sponsor:
Collaborator:
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00490113
First received: June 20, 2007
Last updated: November 5, 2008
Last verified: November 2008
  Purpose

To determine whether pyridoxamine can decrease oxalate excretion in subjects who have normal oxalate excretion (but who have had kidney stones), and in subjects who have primary hyperoxaluria.


Condition Intervention Phase
Kidney Stones
Drug: Pyridoxamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Urinary Excretion of Oxalate at Highest Dose [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Urinary Supersaturation [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2007
Arms Assigned Interventions
Experimental: 1 Drug: Pyridoxamine
Two 250 mg capsules, or placebo, given twice a day for four, 4 week periods. Subjects with primary hyperoxaluria will aslo receive escalated doses up to 3500 mg/day for up to 6 1/2 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults > 18 years
  • History of stone formation
  • Good Renal function
  • Normal urinary excretion of stone-promoting chemicals(Ca, uric acid, oxalate, citrate), except for subjects with hyperoxaluria for Study

Exclusion Criteria:

  • Pregnancy
  • Hyperparathyroidism
  • Enteric hyperoxaluria.
  • Obstructive uropathy
  • Infection (struvite) stones
  • Severe dietary Ca++ restriction or deficiency
  • Recent significant cardio-vascular events
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490113

Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Jon I Scheinman, M.D. University of Kansas
  More Information

No publications provided

Responsible Party: Jon I Scheinman, M.D., University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00490113     History of Changes
Other Study ID Numbers: 10417, 1 R21 DK072454-02
Study First Received: June 20, 2007
Last Updated: November 5, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases
Pyridoxamine
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 29, 2014