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

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 no...

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Autores principales: Gray, Jennifer N., Wolf-Doty, Theresa, Sulejmani, Nimisha, Gaber, Osama, Axelrod, David, Abdalla, Basmah, Danovitch, Gabriel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712506/
https://www.ncbi.nlm.nih.gov/pubmed/33007896
http://dx.doi.org/10.3390/mps3040068
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author Gray, Jennifer N.
Wolf-Doty, Theresa
Sulejmani, Nimisha
Gaber, Osama
Axelrod, David
Abdalla, Basmah
Danovitch, Gabriel
author_facet Gray, Jennifer N.
Wolf-Doty, Theresa
Sulejmani, Nimisha
Gaber, Osama
Axelrod, David
Abdalla, Basmah
Danovitch, Gabriel
author_sort Gray, Jennifer N.
collection PubMed
description 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.
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spelling pubmed-77125062020-12-04 KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol Gray, Jennifer N. Wolf-Doty, Theresa Sulejmani, Nimisha Gaber, Osama Axelrod, David Abdalla, Basmah Danovitch, Gabriel Methods Protoc Protocol 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. MDPI 2020-09-30 /pmc/articles/PMC7712506/ /pubmed/33007896 http://dx.doi.org/10.3390/mps3040068 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Gray, Jennifer N.
Wolf-Doty, Theresa
Sulejmani, Nimisha
Gaber, Osama
Axelrod, David
Abdalla, Basmah
Danovitch, Gabriel
KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
title KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
title_full KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
title_fullStr KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
title_full_unstemmed KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
title_short KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
title_sort kidneycare guided immuno-optimization in renal allografts: the kira protocol
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7712506/
https://www.ncbi.nlm.nih.gov/pubmed/33007896
http://dx.doi.org/10.3390/mps3040068
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