Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

NCT00588120 | Completed Phase 1 DMC

• 3 other identifiers: 1026-98RFA-OD-08-0011U54DK083908-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteric Hyperoxaluria; Hyperoxaluria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

C-13 labeled oxalate

EXPERIMENTAL

Hyperoxaluric patients

Drug: C-13 labeled oxalate

Interventions

C-13 labeled oxalate DRUG

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.

Also known as: oxalate

C-13 labeled oxalate

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Oxalosis and Hyperoxaluria Foundation (OHF): collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hyperoxaluria

Interventions

Oxalates

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dawn Milliner

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Study Start: December 1, 1998
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

US (1)