KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol

Methods and Protocols

JenniferN. Gray¹  Nimisha Sulejmani¹  Theresa Wolf-Doty¹  David Axelrod²  Osama Gaber³  Basmah Abdalla⁴  Gabriel Danovitch⁴ 

[1] CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA;Department of Surgery, University of Iowa Medical Center, 200 Hawkins Dr, Iowa City, IA 52242, USA;Houston Methodist Hospital, 6565 Fannin St. Houston, TX 77030, USA;UCLA Medical Center, 757 Westwood Plaza, Los Angeles, CA 90095, USA;

关键词: immunominimization;    renal transplant;    kidney transplant;    cell-free DNA;    dd-cfDNA;    immuno-optimization;   

DOI  :  10.3390/mps3040068

来源: DOAJ

【 摘 要 】

Immunosuppressant agents are essential in every transplant recipient’s care yet walking the fine line of over- or under-immunosuppression is a constant struggle for both patients and transplant providers alike. Optimization and personalization of immunosuppression has been limited by the need for non-invasive graft surveillance methods that are specific enough to identify organ injury in real time. With this in mind, we propose a pilot study protocol utilizing both donor derived cell free DNA (dd-cfDNA, gene expression profiling (GEP), and machine learning (iBox), called KidneyCare, to assess the feasibility and safety in reducing immunosuppressant exposure without increasing the risk of clinical rejection, graft injury, or allograft loss. Patients randomized to the immunominimization arm will be enrolled in one of two protocols designed to eliminate one immunosuppressant and optimize the dose of the Calcineurin Inhibitors (CNIs) using the KidneyCare platform. All patients will be maintained on dual therapy of either steroids and a low dose CNI, or mycophenolate mofetil (MMF) and low dose CNI. Their outcomes will be compared to patients who have their immunosuppressants managed using standard clinical assessment and treatment protocols to determine the impact of immuno-optimization on graft function, complications, and patient reported outcomes.

【 授权许可】

Unknown