APOL1 Gene Variants in African American Kidney Transplant Recipients

Terminated

• Conditions: Transplant;Failure,Kidney; Kidney Disease; Kidney Failure, Chronic

• Registration Number: NCT01442402
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Study Start: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Allograft survival	year 1, 3, 5

Secondary Outcome Measures

Name	Time	Method
Allograft function as measured by serum creatinine	creatinine levels at year-1, year-3 and year-5

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States