7/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

项目总结

PROJECT SUMMARY APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center We submit this application in response to RFA-DK-22-506. The Cleveland Clinic and the University of Michigan form the Clinical Center 7 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 Midwest. This has been achieved through a very close collaboration between all site PIs and research coordinators. The following transplant centers are part of CC7: Cleveland Clinic in Cleveland, Ohio, Cleveland Clinic in Weston, Florida, University of Michigan, Saint John’s Hospital in Detroit Michigan, Mercy Health St. Mary’s in Michigan, University of Toledo, University of Cincinnati, Ohio State University, University Hospitals of Cleveland, University of Pittsburgh Medical Center, SUNY Foundation/University of Buffalo, Henry Ford Health System and University of Chicago. They are participating as engaged sites. In Phase 1 of APOLLO, we have successfully consented 281 kidney transplant recipients and 33 living donors, with DNA on hand in 246 recipients (91%) and 33 donors (100%), across these 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. In Phase 2, we will continue to obtain critical follow-up data on all participants and ensure completion of data abstraction from electronic medical records, 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 Michigan and The Cleveland Clinic 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 to ensure return of genotype results to all participants who desire this information. We will also continue to recruit living donors at our sites. 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.