Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

APOL1 Gene Variants in African American Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01442402
Recruitment Status : Terminated (Lack of funding/resources)
First Posted : September 28, 2011
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Anil K. Chandraker, MD, Brigham and Women's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Transplant;Failure,Kidney Kidney Disease Kidney Failure, Chronic

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Allograft survival [ Time Frame: year 1, 3, 5 ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
African American Renal Transplant Patients
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Anil K Chandraker, MD Brigham and Women's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic