NCT04430426

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
62mo left

Started Jul 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
7.1 years until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2031

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2032

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

4.1 years

First QC Date

June 10, 2020

Last Update Submit

July 16, 2026

Conditions

Kidney StoneUrolithiasis, Calcium Oxalate

Keywords

kidney stoneoxalate

Outcome Measures

Primary Outcomes (1)

  • Urinary Oxalate Excretion

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

    Baseline through Day 4

Study Arms (1)

Controlled Dietary Study

EXPERIMENTAL

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

Other: Controlled Diet

Interventions

Controlled DietOTHER

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

Controlled Dietary Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant individuals
  • individuals who are currently breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasis, Calcium Oxalate

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kyle Wood, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2032

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)