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Heterozygous Individuals for AGXT and Kidney Stones

Primary Purpose

Kidney Stone

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Controlled Diet
Glycolate Administration
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Stone focused on measuring kidney stone, oxalate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Controlled Dietary Study

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2020
    Last Updated
    February 1, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04430426
    Brief Title
    Heterozygous Individuals for AGXT and Kidney Stones
    Official Title
    Heterozygous Individuals for AGXT and Kidney Stones
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Stone
    Keywords
    kidney stone, oxalate

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Controlled Dietary Study
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Controlled Diet
    Intervention Description
    Participants will consume a controlled low oxalate diet for five days.
    Intervention Type
    Other
    Intervention Name(s)
    Glycolate Administration
    Intervention Description
    Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.
    Primary Outcome Measure Information:
    Title
    Urinary Oxalate Excretion
    Description
    Urinary oxalate excretion from urine samples will be measured as mg/day
    Time Frame
    Baseline through Day 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Demond Wiley
    Phone
    205-934-3671
    Email
    kidneystone@uabmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyle Wood, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Heterozygous Individuals for AGXT and Kidney Stones

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