Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

Hyperoxaluria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588120
• Other study ID #: 1026-98
• Secondary ID: RFA-OD-08-0011U5
• Status: Completed
• Phase: Phase 1
• Start date: December 1998
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enteric Hyperoxaluria
• Hyperoxaluria

Intervention

Drug:
• C-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.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Oxalosis and Hyperoxaluria Foundation (OHF)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine oxalate measured following absorption of oral oxalate dose	Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours.	2 years

External Links

•   Mayo Clinic Clinical Trials