APOL1 Gene Variants in African American Kidney Transplant Recipients

NCT ID: NCT01442402

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Transplant;Failure,Kidney Kidney Disease Kidney Failure, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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2 APOL1 genotypes

African American transplant recipients with homozygous APOL1 gene variants

No interventions assigned to this group

0 or 1 APOL1 genotypes

African American transplant recipients without homozygous APOL1 gene variants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* self-reported African American
* 18 years or older
* kidney transplant within 12 years

Aim 2:


* self-reported African American
* 18 years or older
* kidney transplant within 12 years
* recurrent or de novo glomerular disease on allograft kidney biopsy


* 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


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

Exclusion Criteria

* clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine \>2)

Aim 3:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anil K. Chandraker, MD

Medical Director of Renal Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anil K Chandraker, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2011P000734

Identifier Type: -

Identifier Source: org_study_id

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