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Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

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Mayo Clinic

Status and phase

Completed
Phase 1

Conditions

Hyperoxaluria
Enteric Hyperoxaluria

Treatments

Drug: C-13 labeled oxalate

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00588120
1U54DK083908-01 (U.S. NIH Grant/Contract)
1026-98
RFA-OD-08-001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

4+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

114 participants in 1 patient group

C-13 labeled oxalate
Experimental group
Description:
Hyperoxaluric patients
Treatment:
Drug: C-13 labeled oxalate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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