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

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


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.

Original languageEnglish (US)
Article number68
Pages (from-to)1-9
Number of pages9
JournalMethods and Protocols
Issue number4
StatePublished - Sep 30 2020


  • Calcineurin inhibitor minimization
  • Cell-free DNA
  • Corticosteroid withdrawal
  • Dd-cfDNA
  • Immuno-optimization
  • Immunominimization
  • Immunosuppression
  • Kidney transplant
  • Renal transplant

ASJC Scopus subject areas

  • Biotechnology
  • Structural Biology
  • Biochemistry, Genetics and Molecular Biology (miscellaneous)


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