Heterozygous Individuals for AGXT and Kidney Stones

NCT ID: NCT04430426

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2032-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Stone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Controlled Dietary Study

Participants will consume the controlled diet for five days and be administered an intravenous (IV) load of glycolate. Participants will provide urine and blood samples both before the glycolate load to establish baseline levels and after the glycolate load to measure oxalate levels afterwards.

Group Type EXPERIMENTAL

Controlled Diet

Intervention Type OTHER

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

Glycolate Administration

Intervention Type OTHER

Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.

Interventions

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Controlled Diet

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

Intervention Type OTHER

Glycolate Administration

Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Kyle D. Wood

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyle Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Central Contacts

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Demond Wiley

Role: CONTACT

205-934-3671

Other Identifiers

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IRB-300005327

Identifier Type: -

Identifier Source: org_study_id

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