To test kidney donors and transplant recipients for forms of the APOL1 gene for purposes of evaluating how the various forms may impact both donors and recipients. To determine whether the presence of APOL1 RRVs in a kidney donor shortens death-censored renal allograft survival. Secondary Objectives: 1. Define whether the presence of APOL1 RRVs in a kidney donor is associated with worse renal function or greater proteinuria after transplantation of the kidney; 2. Define whether the presence of APOL1 RRVs is associated with worse renal outcomes in living kidney donors after nephrectomy, and; 3. (if donor APOL1 RRVs are associated with worse kidney function in recipients of renal allografts) identify modifying factors that increase susceptibility for shortened allograft survival, reduced renal allograft function or greater proteinuria in recipients of kidneys from donors with APOL1 high-risk genotypes. Modifying factors may include cause of death in the deceased donor, ischemia time, type of immunosuppression, graft rejection, viral infection, post-engraftment renal dysfunction, etc.
APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a prospective manner. In this protocol, recent African ancestry is broadly defined as African American, Afro-Caribbean, Hispanic black, and African.More
Child to Adult
Inclusion Criteria for Living Donors: 1. Living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African) Exclusion Criteria for Living Donors: 1. Participants who are unable or unwilling to provide informed consent 2. Biracial or multiracial ____________________________________________________________________________________ Inclusion Criteria for Recipients: 1. Recipients of a kidney transplant from an eligible living or deceased donor with recent African ancestry 2. Recipients of multi-organ transplants including a kidney plus an additional organ (i.e. liver, heart, lung, pancreas, etc.) or pediatric en bloc and dual kidney transplants Exclusion Criteria for Recipients: 1. Participants who are unable or unwilling to provide informed consent.
University of Colorado Hospital
Protocol Number: 19-0461
More information available at ClinicalTrials.gov: NCT03615235
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