Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588120
Recruitment Status : Active, not recruiting
First Posted : January 8, 2008
Last Update Posted : June 19, 2017
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oxalosis and Hyperoxaluria Foundation (OHF)
Information provided by (Responsible Party):
John Lieske, 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.

Condition or disease Intervention/treatment Phase
Enteric Hyperoxaluria Hyperoxaluria Drug: C-13 labeled oxalate Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study
Study Start Date : December 1998
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: C-13 labeled oxalate
Hyperoxaluric patients
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.

Other Name: oxalate

Primary Outcome Measures :
  1. Urine oxalate measured following absorption of oral oxalate dose [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588120

United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oxalosis and Hyperoxaluria Foundation (OHF)
Principal Investigator: Dawn Milliner Mayo Clinic

Additional Information:
Responsible Party: John Lieske, Principal Investigator, Mayo Clinic Identifier: NCT00588120     History of Changes
Other Study ID Numbers: 1026-98
RFA-OD-08-001 ( Other Grant/Funding Number: Rare Diseases Clinical Research Consortia )
1U54DK083908-01 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017

Keywords provided by John Lieske, Mayo Clinic:
Unknown Hyperoxaluria
Enteric Hyperoxaluria
High Oxalate
Oxalate Diet