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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This study has been withdrawn prior to enrollment.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:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00490113
First received: June 20, 2007
Last updated: January 3, 2017
Last verified: January 2017
  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
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 Medical Center:

Primary Outcome Measures:
  • Urinary Excretion of Oxalate at Highest Dose [ Time Frame: 4 Weeks ]

Secondary Outcome Measures:
  • Change in Urinary Supersaturation [ Time Frame: 4 Weeks ]

Enrollment: 0
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   (Adult, Senior)
Sexes Eligible for Study:   All
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 Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jon I Scheinman, M.D. University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00490113     History of Changes
Other Study ID Numbers: 10417
1R21DK072454-02 ( US NIH Grant/Contract Award Number )
Study First Received: June 20, 2007
Last Updated: January 3, 2017

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

ClinicalTrials.gov processed this record on March 24, 2017