APOL1 Gene Variants in African American Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT01442402|
Recruitment Status : Terminated (Lack of funding/resources)
First Posted : September 28, 2011
Last Update Posted : January 27, 2021
Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans
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
Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.
|Condition or disease|
|Transplant;Failure,Kidney Kidney Disease Kidney Failure, Chronic|
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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
- Allograft survival [ Time Frame: year 1, 3, 5 ]
- Allograft function as measured by serum creatinine [ Time Frame: creatinine levels at year-1, year-3 and year-5 ]
Biospecimen Retention: Samples With DNA
Aims 1 and 2:
Subjects will collect a saliva specimen in an Oragene®•DNA sample collection kit for genotyping. We will also collected any discarded (no longer utilized for clinical purposes) tissue from biopsies.
Prior to transplant, subjects will collect saliva in an Oragene®•DNA sample collection kit for genotyping and 10cc of blood will be drawn into a Na heparin collection tube for APOL1 protein analysis. When applicable, plasmapheresis effluent will be collected. We will also collected any discarded (no longer utilized for clinical purposes)tissue from biopsies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442402
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Anil K Chandraker, MD||Brigham and Women's Hospital|