Kidney StoneNCT04430426
Heterozygous Individuals for AGXT and Kidney Stones
A study of Kidney Stone and Urolithiasis, Calcium Oxalate, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Urolithiasis, Calcium Oxalate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 1 Aug 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant individuals
- individuals who are currently breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
- Conditions
- Kidney Stone, Urolithiasis, Calcium Oxalate
- Being tested
- Controlled Diet
- Keywords
- kidney stone, oxalate
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Calcium Oxalate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled DietOther
Participants will consume a controlled low oxalate diet for five days.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Dietary Study | Experimental | Participants will consume the controlled diet for five days. Participants will provide urine and blood samples to measure oxalate levels. Receives: Other: Controlled Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Oxalate Excretion
Urinary oxalate excretion from urine samples will be measured as mg/day
Measured: Baseline through Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jul 2027 (estimated)
- Primary completion1 Aug 2031 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle D. Wood, University of Alabama at Birmingham
- Investigators
- Kyle Wood, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430426
- Sponsor's protocol ID
- IRB-300005327
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No