APOL1 Gene Variants in African American Kidney Transplant Recipients

January 25, 2021 updated by: Anil K. Chandraker, MD, Brigham and Women's Hospital

Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

African American Renal Transplant Patients

Description

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 >2)

Aim 3:

Inclusion Criteria:

  • self-reported African American
  • 18 years or older
  • scheduled living kidney transplant

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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Allograft survival
Time Frame: year 1, 3, 5
year 1, 3, 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Allograft function as measured by serum creatinine
Time Frame: creatinine levels at year-1, year-3 and year-5
creatinine levels at year-1, year-3 and year-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

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

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

April 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P000734

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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