APOL1 Gene Variants in African American Kidney Transplant Recipients
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| First Received Date ICMJE | September 27, 2011 | ||||||||
| Last Updated Date | May 14, 2012 | ||||||||
| Start Date ICMJE | June 2011 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT01442402 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | APOL1 Gene Variants in African American Kidney Transplant Recipients | ||||||||
| Official Title ICMJE | Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | African American Renal Transplant Patients |
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| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Group/Cohort (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 190 | ||||||||
| Estimated Completion Date | June 2014 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Aim 1: Inclusion Criteria:
Aim 2: Inclusion Criteria for patients with recurrent disease:
Inclusion Criteria for control group:
Exclusion Criteria for control group:
Aim 3: Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01442402 | ||||||||
| Other Study ID Numbers ICMJE | 2011P000734 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Anil K. Chandraker, MD, Brigham and Women's Hospital | ||||||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||
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| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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