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Updated: Dec 7, 2025
Robot-Assisted Kidney Transplantation
Published on: July 19, 2021
KidneyCare Guided Immuno-Optimization in Renal Allografts: The KIRA Protocol
Jennifer N Gray1, Theresa Wolf-Doty1, Nimisha Sulejmani1
1CareDx, 3260 Bayshore Blvd, Brisbane, CA 94005, USA.
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.
Insights
This pilot study explores a new KidneyCare platform using donor-derived cell-free DNA (dd-cfDNA), gene expression profiling (GEP), and machine learning (iBox) to personalize immunosuppression in kidney transplant recipients, aiming to reduce drug exposure safely.
Area of Science:
- Nephrology
- Immunology
- Biotechnology
Background:
- Optimizing immunosuppression in transplant recipients is challenging due to the lack of non-invasive, real-time graft surveillance methods.
- Over- or under-immunosuppression poses significant risks, including rejection, graft injury, and allograft loss.
Purpose of the Study:
- To assess the feasibility and safety of the KidneyCare platform for personalized immunosuppression in kidney transplant recipients.
- To evaluate the potential of reducing immunosuppressant exposure without compromising graft outcomes.
Main Methods:
- A pilot study protocol utilizing donor-derived cell-free DNA (dd-cfDNA), gene expression profiling (GEP), and machine learning (iBox) – termed KidneyCare.
- Patients randomized to an immunominimization arm will follow protocols to reduce one immunosuppressant and optimize Calcineurin Inhibitor (CNI) doses.
- Comparison of outcomes between the KidneyCare-guided immunominimization arm and standard clinical management.
Main Results:
- The study aims to determine the impact of immuno-optimization on graft function, complications, and patient-reported outcomes.
- Evaluating the safety and efficacy of reducing immunosuppressant exposure through personalized monitoring.
Conclusions:
- The KidneyCare platform offers a novel approach to personalized immunosuppression management in kidney transplantation.
- Successful implementation could lead to safer, more effective immunosuppressive strategies, improving long-term graft survival and patient quality of life.
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