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

Jennifer N. Gray; Theresa Wolf-Doty; Nimisha Sulejmani; Osama Gaber; David Axelrod; Basmah Abdalla; Gabriel Danovitch

doi:10.3390/mps3040068

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

Journal article

Open access

Peer reviewed

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

Jennifer N. Gray, Theresa Wolf-Doty, Nimisha Sulejmani, Osama Gaber, David Axelrod, Basmah Abdalla and Gabriel Danovitch

Methods and protocols, Vol.3(4), pp.1-9

12/01/2020

DOI: 10.3390/mps3040068

PMCID: PMC7712506

PMID: 33007896

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Abstract

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.

Biochemical Research Methods

Biochemistry & Molecular Biology

Life Sciences & Biomedicine

Science & Technology

Details

Title: Subtitle: KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
Creators: Jennifer N. Gray - CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.
Theresa Wolf-Doty - CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.
Nimisha Sulejmani - CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.
Osama Gaber - Houston Methodist
David Axelrod - University of Iowa
Basmah Abdalla - UCLA Medical Center
Gabriel Danovitch - Ronald Reagan UCLA Medical Center
Resource Type: Journal article
Publication Details: Methods and protocols, Vol.3(4), pp.1-9
DOI: 10.3390/mps3040068
PMID: 33007896
PMCID: PMC7712506
NLM abbreviation: Methods Protoc
ISSN: 2409-9279
eISSN: 2409-9279
Publisher: Mdpi
Number of pages: 9
Language: English
Date published: 12/01/2020
Academic Unit: Surgery
Record Identifier: 9984322957002771

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