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
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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.
Condition or disease |
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Transplant;Failure,Kidney Kidney Disease Kidney Failure, Chronic |
Study Type : | Observational |
Actual Enrollment : | 39 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
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 |

Group/Cohort |
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2 APOL1 genotypes
African American transplant recipients with homozygous APOL1 gene variants
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0 or 1 APOL1 genotypes
African American transplant recipients without homozygous APOL1 gene variants
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- 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.
Aim 3:
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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 |
Responsible Party: | Anil K. Chandraker, MD, Medical Director of Renal Transplantation, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT01442402 |
Other Study ID Numbers: |
2011P000734 |
First Posted: | September 28, 2011 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Kidney Diseases Renal Insufficiency Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic |