Outcomes at 3 years post-transplant in imlifidase-desensitized kidney transplant patients

Christian Kjellman, Angela Q. Maldonado, Kristoffer Sjöholm, Bonnie E. Lonze, Robert A. Montgomery, Anna Runström, Tomas Lorant, Niraj M. Desai, Christophe Legendre, Torbjörn Lundgren, Bengt von Zur Mühlen, Ashley A. Vo, Håkan Olsson, Stanley C. Jordan

Research output: Contribution to journalArticlepeer-review

Abstract

Imlifidase is a cysteine proteinase which specifically cleaves IgG, inhibiting Fc-mediated effector function within hours of administration. Imlifidase converts a positive crossmatch to a potential donor (T cell, B cell, or both), to negative, enabling transplantation to occur between previously HLA incompatible donor-recipient pairs. To date, 39 crossmatch positive patients received imlifidase prior to a kidney transplant in four single-arm, open-label, phase 2 studies. At 3 years, for patients who were AMR+ compared to AMR−, death-censored allograft survival was 93% vs 77%, patient survival was 85% vs 94%, and mean eGFR was 49 ml/min/1.73 m2 vs 61 ml/min/1.73 m2, respectively. The incidence of AMR was 38% with most episodes occurring within the first month post-transplantation. Sub-analysis of patients deemed highly sensitized with cPRA ≥ 99.9%, and unlikely to be transplanted who received crossmatch-positive, deceased donor transplants had similar rates of patient survival, graft survival, and eGFR but a higher rate of AMR. These data demonstrate that outcomes and safety up to 3 years in recipients of imlifidase-enabled allografts is comparable to outcomes in other highly sensitized patients undergoing HLA-incompatible transplantation. Thus, imlifidase is a potent option to facilitate transplantation among patients who have a significant immunologic barrier to successful kidney transplantation. Clinical Trial: ClinicalTrials.gov (NCT02790437), EudraCT Number: 2016-002064-13.

Original languageEnglish (US)
JournalAmerican Journal of Transplantation
DOIs
StateAccepted/In press - 2021

Keywords

  • alloantibody
  • clinical research/practice
  • crossmatch
  • desensitization
  • immunosuppressant – other
  • immunosuppression/immune modulation
  • kidney transplantation/nephrology
  • sensitization

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

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