Overview

This trial is active, not recruiting.

Conditions enteric hyperoxaluria, hyperoxaluria
Treatment c-13 labeled oxalate
Phase phase 1
Sponsor Mayo Clinic
Collaborator National Institutes of Health (NIH)
Start date December 1998
End date October 2015
Trial size 125 participants
Trial identifier NCT00588120, 1026-98, 1U54DK083908-01, RFA-OD-08-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Hyperoxaluric patients
c-13 labeled oxalate oxalate
A single prescribed dose of C-13 labeled oxalate will be given orally in capsule form or in jello. Urine will be collected for 24 hours after the dose. Take one capsule by mouth for one day.

Primary Outcomes

Measure
Urine oxalate measured following absorption of oral oxalate dose
time frame: 2 years

Eligibility Criteria

Male or female participants at least 4 years old.

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

Additional Information

Official title Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study
Principal investigator Dawn Milliner
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.