Clinical Trial TitleAPOL1 Long-term Kidney Transplantation Outcomes (APOLLO) Study. APOLLO - UPPER MIDWEST U01DK116092
National Clinical Trial Number:NCT03615235
Clinical Trial Protocol Description:
The National Institutes of Health (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa.
APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.
Clinical Trial Eligibility Criteria:
The objectives of APOLLO inclusion/exclusion criteria are to identify every living kidney donor with recent African ancestry, as well as every recipient of a kidney from a donor in the continental United States, Hawaii and Puerto Rico with recent African ancestry. APOLLO will prospectively capture data from all consenting living and eligible deceased kidney donors with recent African ancestry and recipients of their kidneys. The study will determine whether APOL1-based precision medicine can better inform decisions for the allocation of deceased and living-donor kidneys, improve matching of kidneys with recipients to yield longer graft survival, and reduce ethnic disparities in outcomes. Thus, every transplant program in the continental U.S., Hawaii and Puerto Rico is aligned with one of 13 APOLLO CCs to achieve these objectives. The Principal Investigator at each CC will be responsible for participant recruitment at their aligned transplant programs. Inclusion/exclusion criteria were intentionally developed to be simple, facilitating standard implementation across all APOLLO CCs and OPOs.