Living Donor Extended Time Outcomes (LETO) Study

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PROJECT SUMMARY We are submitting this competitive revision application in response to NOT-DK-20-012 to expand our existing R01DK120551 project titled “Living donor Extended Time Outcomes (LETO).” The parent LETO study will recruit a national sample of 1,100 black living kidney donors to assess their health status ~15-20 years after donation. The primary aim of the original application is to determine in a national sample whether black living kidney donors with 2 apolipoprotein L1 gene (APOL1) renal-risk variants are at higher risk of developing clinically significant chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73m2) approximately two decades after donation.” Only black donors are targeted for enrollment into the parent LETO study. In this revision R01DK120551 application, we propose to add enrollment of 500 white living kidney donors, which will convert LETO into a powerful research platform to study racial disparities. This expansion will allow us to address a new aim: to quantify and compare the risk of developing clinically significant chronic kidney disease approximately two decades after donation in a national sample of black vs. white living kidney donors, and to quantify the relative importance of biologic (genetic, unmodifiable) vs. non- biologic (non-genetic, potentially modifiable) factors contributing to any observed health disparity. We will use the same cost-effective “hybrid” study design—jointly analyzing data collected at home-based research visits together with data collected as part of clinical care (as entered into a national registry)—that greatly increases the number of person-years of follow-up and enhances study power. We believe that findings from this study will strongly advocate for the adoption of policies such as such as mechanisms for improved long-term follow-up and provision of lifelong health insurance to living donors--justified not only as a moral imperative but also as a powerful tool to reduce racial disparities in access to living donor transplant.