14/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Scientific Data Research Center

The NIH APOL1 Long-term Transplantation Outcomes Network (APOLLO) Collaborative U01 is performing a national prospective evaluation of donor and recipient apolipoprotein L1 gene (APOL1) risk variants in US kidney transplants from African American donors to determine their effect on transplant outcomes. In addition, post- donation health and kidney function of African American living kidney donors will be assessed. We are applying to continue serving as the APOLLO Scientific and Data Research Center (SDRC). Shorter renal allograft survival is observed for transplantations from deceased African American kidney donors, relative to deceased European American kidney donors. Reasons for this are unknown, but retrospective reports suggest that presence of two APOL1 risk variants in kidney donors may contribute to the disparity. These variants are common in populations with recent African ancestry (such as African Americans), where they are strongly associated with chronic kidney disease, but rare in other racial/ethnic groups. APOL1 genotype data may provide more accurate assessment of the likelihood for long-term renal allograft function in donor kidneys, thereby improving matching of donor kidneys with potential recipients in order to optimize renal allograft and patient survival. This information may better inform physicians about organ quality prior to making decisions on allocation. It may also inform the safety of living kidney donation. Before APOL1 genotypes can be used clinically, the prospective national APOLLO study was required to evaluate kidney transplant outcomes from African American donors and recipients of their kidneys based on APOL1. APOLLO collects information lacking from retrospective studies, including recipient APOL1 genotypes, renal histology in engrafted kidneys and presence or development of BK viral infections, donor specific antibodies, and acute rejections after kidney transplantation. We apply to continue to perform these activities for the APOLLO Network: overall study coordination, assist with ensuring compliance with the Protocol and Manual of Procedures, maintain data tracking tools and the study website, collect and archive clinical and outcomes data, perform genotyping, statistical analyses, assessment of outcomes including the primary outcome “time to allograft failure in transplanted kidneys from African American donors based on donor APOL1 genotypes”, and complete the bio-repository. We will longitudinally assess vital status, kidney function and proteinuria in living African American kidney donors based on APOL1 genotypes and prospectively assess effects of donor APOL1 genotypes on serum creatinine concentration, estimated glomerular filtration rate, and proteinuria in kidney transplant recipients with functioning grafts. APOLLO results have the potential to transform the organ allocation and informed consent processes in kidney transplantation, optimize renal allograft survival, reduce discard of good-quality kidneys, and protect the health of living kidney donors.