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APOL1 Gene Variants in African American Kidney Transplant Recipients

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT01442402
Collaborator
(none)
39
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Aim 1:

Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans

Aim 2:

Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease

Aim 3:

Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    39 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms
    Study Start Date :
    Apr 1, 2014
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    2 APOL1 genotypes

    African American transplant recipients with homozygous APOL1 gene variants
    0 or 1 APOL1 genotypes

    African American transplant recipients without homozygous APOL1 gene variants

    Outcome Measures

    Primary Outcome Measures

    1. Allograft survival [year 1, 3, 5]

    Secondary Outcome Measures

    1. Allograft function as measured by serum creatinine [creatinine levels at year-1, year-3 and year-5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Aim 1:
    Inclusion Criteria:

    • self-reported African American

    • 18 years or older

    • kidney transplant within 12 years

    Aim 2:
    Inclusion Criteria for patients with recurrent disease:

    • self-reported African American

    • 18 years or older

    • kidney transplant within 12 years

    • recurrent or de novo glomerular disease on allograft kidney biopsy

    Inclusion Criteria for control group:

    • self-reported African American

    • 18 years or older

    • kidney transplant within 12 years

    • end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy

    Exclusion Criteria for control group:
    • clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine
    Aim 3:
    Inclusion Criteria:

    • self-reported African American

    • 18 years or older

    • scheduled living kidney transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Anil K Chandraker, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anil K. Chandraker, MD, Medical Director of Renal Transplantation, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT01442402
    Other Study ID Numbers:
    • 2011P000734
    First Posted:
    Sep 28, 2011
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Jan 27, 2021