1-13 ApoL1 Genotypes in Kidney Donors and Long-Term Outcomes in Kidney Transplant Recipients Clinical Center

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PROJECT SUMMARY APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center We submit this application in response to RFA-DK-22-506. The University of Miami, Miami Transplant Institute, Jackson Memorial Hospital is the Clinical Center 11 which is a current member of the APOLLO Consortium. This Consortium was established in 2017 to work seamlessly with the Association of Organ Procurement Organizations (AOPO) to enroll participants in the largest observational study to date of kidney transplant recipients and donors to evaluate APOL1 gene mutations in kidney donor as a risk factor for graft loss. Our Clinical Center has been a leader and top enroller for eligible recipients and living kidney donors in the state of Florida, Puerto Rico and 2 transplant centers in California. This has been achieved through a very close collaboration between all site PIs and research coordinators. The following transplant centers are part of CC11: participating as engaged centers are: The Miami Transplant Institute, Tampa General Hospital, Mayo Clinic Jacksonville, the University of Florida; participating as non-engaged centers are: Advent Health Orlando Florida, Memorial Healthcare System Broward Hospital Florida, Auxilio Mutuo Hospital in Puerto Rico, California Institute of Renal Research and University of California, Irvine. In Phase 1 of APOLLO, we have successfully consented 241 kidney transplant recipients and 20 living donors, with DNA on hand in 220 recipients (91%) and 20 donors (100%), across all centers. Our site has overseen the careful collection of clinical data from the electronic medical record at our own site and subsites to complete the APOLLO Consortium Data Forms accurately and entirely, with 97% to 100% of the data entry at various data points. In Phase 2, we will continue to obtain critical follow-up data on all participants and ensure completion of data abstraction from electronic medical record, to provide patient-level detail not available in databases maintained by United Network for Organ Sharing (UNOS) and the Scientific Registry of Transplant Recipients (SRTR). We will ensure a urine albumin-to-creatinine ratio is measured in all participants, at all sites, at a longitudinal follow-up time point of at least two years from original enrollment in APOLLO Phase 1. The University of Miami, Miami Transplant Institute, will continue to collect additional biospecimens for contribution to the biorepository as well as unstained biopsy slides as we have been doing through Phase 1. We will work with the Scientific Data and Research Center (SDRC) to ensure return of genotype results to all participants who desire this information. We will also continue to recruit living donors at the Miami Transplant Institute. Continuation of the APOLLO Consortium will lead to important advances in our understanding of APOL1 high-risk status and its influence on graft function as well as the biology of APOL1 gene effects.