- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430426
Heterozygous Individuals for AGXT and Kidney Stones
January 18, 2024 updated by: Kyle D. Wood, University of Alabama at Birmingham
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Demond Wiley
- Phone Number: 205-934-3671
- Email: kidneystone@uabmc.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants will consume a controlled low oxalate diet for five days.
Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary Oxalate Excretion
Time Frame: Baseline through Day 6
|
Urinary oxalate excretion from urine samples will be measured as mg/day
|
Baseline through Day 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kyle Wood, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
June 10, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 12, 2020
Study Record Updates
Last Update Posted (Estimated)
January 19, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Urolithiasis
- Urinary Calculi
- Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Calculi
- Nephrolithiasis
- Dermatologic Agents
- Keratolytic Agents
- Glycolic acid
Other Study ID Numbers
- IRB-300005327
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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