APOL1 Gene Variants in African American Kidney Transplant Recipients

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01442402

Enrollment

Registered

2011-09-28

Start date

2014-04-30

Completion date

2014-04-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease, Kidney Failure, Chronic, Transplant;Failure,Kidney

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Allograft survival	year 1, 3, 5

Secondary

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

Countries

United States

Outcome results