Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00588120

Enrollment

114

Registered

2008-01-08

Start date

1998-12-31

Completion date

2020-01-31

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteric Hyperoxaluria, Hyperoxaluria

Keywords

Hyperoxaluria, Unknown Hyperoxaluria, Enteric Hyperoxaluria, Oxaluric, High Oxalate, Oxalate, C13, Oxalate Diet

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.

Interventions

DRUGC-13 labeled 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026