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

This study has been withdrawn prior to recruitment.

Sponsors and Collaborators:	University of Kansas National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00490113

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria

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
1: Experimental	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

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

Sponsors and Collaborators

University of Kansas

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Jon I Scheinman, M.D.

University of Kansas

More Information

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Hyperoxaluria

Pyridoxamine
Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:

Vitamin B Complex
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009