Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

Phase 1

Completed

• Conditions: Enteric Hyperoxaluria; Hyperoxaluria
• Interventions: Drug: C-13 labeled oxalate

• Registration Number: NCT00588120
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.

Detailed Description

Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-08
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Age equal to or greater than 4 years (patient must be able to void on request).
• Have good health.

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Exclusion Criteria

• Any prior history of renal disease, or hypertension
• ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study.
• Subjects with GFR < 50 cc/min will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-13 labeled oxalate	C-13 labeled oxalate	Hyperoxaluric patients

Primary Outcome Measures

Name	Time	Method
Urine oxalate measured following absorption of oral oxalate dose	2 years	Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours.

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States