*Purpose: Detecting allograft injury and rejection is critical to preventing graft loss. Current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kidney injury earlier. SC has poor specificity and sensitivity and response to rejection is often delayed. Protocol biopsy is more accurate but involves the risk of complications. A more definitive, less invasive method for monitoring injury and early rejection is needed.We report on the clinical utility of donor-derived cell-free DNA (dd-cfDNA) in transplant recipients’ blood, measured using a novel SNP-based mmPCR NGS methodology, to diagnose allograft injury/rejection. In this study, we measure how use of dd-cfDNA changes clinical practice.

*Methods: This randomized controlled trial studies provider practice in a representative sample of 150+ practicing nephrologists. Over two rounds, providers outline care for six online, virtual patients, representing a cross-section of renal transplant patients (adults aged 30-75, 3-24 months post-transplant with findings suggestive of allograft rejection). Intervention arm physicians receive educational materials on the dd-cfDNA test between rounds and are given dd-cfDNA test results when caring for patients in round 2.

*Results: We hypothesize clinical workup of kidney injury in post-transplant patients is highly variable and sub-optimal, and that introduction of this test results in more timely biopsies, fewer unnecessary biopsies and earlier detection of rejection. Preliminary results from 73 nephrologists who cared for 211 allograft cases show that in those with no rejection, treated according to SoC, 44% (19/43) received an unnecessary biopsy. Additionally, in cases with rejection, only 30% (50/168) received an appropriate biopsy. We will measure: (1) overall adherence to evidence-based standards, (2) ability to diagnose and treat kidney rejection, and (3) how incorporation of the dd-cfDNA test into practice changes management and health care costs and utilization.

*Conclusions: This is an ongoing study. We expect to have updated results and conclusion in time for ATC19.

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