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NCT04430426 Clinical Trial

Heterozygous Individuals for AGXT and Kidney Stones

Kidney Stone Clinical Trial

Official title:
Heterozygous Individuals for AGXT and Kidney Stones

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04430426
Other study ID # IRB-300005327
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 2025

Study information
Verified date January 2024
Source University of Alabama at Birmingham
Contact Demond Wiley
Phone 205-934-3671
Email kidneystone@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of glycolate, providing additional blood and urine samples afterwards to measure any increase in oxalate levels.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4
Est. completion date December 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - at least 18 years of age - history of calcium oxalate stones - heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel - willingness to comply with a controlled diet for five days Exclusion Criteria: - pregnant individuals - individuals who are currently breast feeding

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Controlled Diet
Participants will consume a controlled low oxalate diet for five days.
• Glycolate Administration
Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome
Type Measure Description Time frame Safety issue
Primary Urinary Oxalate Excretion Urinary oxalate excretion from urine samples will be measured as mg/day Baseline through Day 6
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