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Enrolling by invitation NCT04430426

Heterozygous Individuals for AGXT and Kidney Stones

No phase Interventional Kidney Stone Urolithiasis, Calcium Oxalate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Controlled Diet.
Who it may be relevant to
Registry conditions: Kidney Stone, Urolithiasis, Calcium Oxalate. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Controlled Diet
    Participants will consume a controlled low oxalate diet for five days.

Primary outcome measures

  • Urinary Oxalate Excretion [Time frame: Baseline through Day 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT04430426 · IRB-300005327

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗