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This study has been withdrawn prior to enrollment.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:
University of Kansas
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 20, 2007 | ||||
| Last Updated Date | November 5, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Urinary Excretion of Oxalate at Highest Dose [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Urinary Excretion of Oxalate at Highest Dose [ Time Frame: 4 Weeks ] | ||||
| Change History | Complete list of historical versions of study NCT00490113 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change in Urinary Supersaturation [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Change in Urinary Supersaturation [ Time Frame: 4 Weeks ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Trial of Pyridoxamine to Lower Urine Oxalate in Subjects With Stone Disease or Hyperoxaluria | ||||
| Official Title ICMJE | Effects of Pyridoxamine on Oxalate Excretion in Stone Disease and Hyperoxaluria | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Kidney Stones | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: Pyridoxamine |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00490113 | ||||
| Other Study ID Numbers ICMJE | 10417, 1 R21 DK072454-02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jon I Scheinman, M.D., University of Kansas Medical Center | ||||
| Study Sponsor ICMJE | University of Kansas | ||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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