A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria
NCT ID: NCT00490113
Last Updated: 2017-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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1
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* Hyperparathyroidism
* Enteric hyperoxaluria.
* Obstructive uropathy
* Infection (struvite) stones
* Severe dietary Ca++ restriction or deficiency
* Recent significant cardio-vascular events
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jon I Scheinman, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Other Identifiers
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10417
Identifier Type: -
Identifier Source: org_study_id
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