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NCT01442402 Clinical Trial

APOL1 Gene Variants in African American Kidney Transplant Recipients

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01442402
Other study ID # 2011P000734
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2014
Est. completion date April 2014

Study information
Verified date January 2021
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 39
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Allograft survival year 1, 3, 5
Secondary Allograft function as measured by serum creatinine creatinine levels at year-1, year-3 and year-5
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