Heterozygous Individuals for AGXT and Kidney Stones

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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Nephrolithiasis, Calcium Oxalate Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urolithiasis, Calcium Oxalate Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled diet

Other

Participants will consume a controlled low oxalate diet for five days.

Primary outcomes

Urinary Oxalate Excretion

Time frame: Baseline through Day 4

Urinary oxalate excretion from urine samples will be measured as mg/day

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start: 2027
Primary completion: 2031
Study completion: 2032
First posted: Jun 12, 2020
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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