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Enrolling by invitationNCT04430426Updated Aug 31, 2026

Heterozygous Individuals for AGXT and Kidney Stones

An interventional study of Controlled Diet in Kidney Stone and Urolithiasis, Calcium Oxalate, sponsored by University of Alabama at Birmingham. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Kidney Stone
  • Urolithiasis, Calcium Oxalate

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Keywords

  • kidney stone
  • oxalate
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In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 4 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • pregnant individuals
  • individuals who are currently breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    Controlled Dietary Study

    Participants will consume the controlled diet for five days. Participants will provide urine and blood samples to measure oxalate levels.

    Other: Controlled Diet

Interventions

  • OtherControlled Diet

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

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What researchers measure

Primary outcomes

  1. Urinary Oxalate Excretion

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

    Time frame: Baseline through Day 4

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Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04430426
Lead sponsor
University of Alabama at Birmingham
Responsible party
Kyle D. Wood (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jun 12, 2020
Start date
Jul 1, 2027 (estimated)
Primary completion
Aug 1, 2031 (estimated)
Completion
Aug 1, 2032 (estimated)
Last update
Aug 31, 2026

Study contacts

Kyle Wood, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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