ORIGINAL RESEARCH

Transpl. Int.

Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients

  • 1. Uppsala Universitet, Uppsala, Sweden

  • 2. NYU Langone Transplant Institute, New York, United States

  • 3. Northwell Health, New Hyde Park, United States

  • 4. Hopital Universitaire Necker-Enfants Malades, Paris, France

  • 5. Karolinska Institutet, Stockholm, Sweden

  • 6. Cedars-Sinai, Los Angeles, United States

  • 7. Hansa Biopharma AB, Lund, Sweden

  • 8. Cedars-Sinai Medical Center, Los Angeles, United States

The final, formatted version of the article will be published soon.

Abstract

In four phase 2 clinical trials, patients underwent imlifidase-enabled kidney transplantation, converting a positive crossmatch (+XM) to negative. Here, we present data from 39 patients enrolled in the 5-year follow-up extension trial. Patient survival, graft survival, renal function, delayed graft function (DGF), antibody mediated rejection (AMR) frequency, safety and presence of donor specific antibodies (DSAs) are presented. Data from the long-term follow-up trial (17-HMedIdeS-14); NCT 03611621) with planned visits at 1, 2, 3, and 5 years after imlifidase were combined with up to 6-month phase 2 data from 4 pivotal trials (13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04, 15-HMedIdeS-06). Five-year patient survival was 90% with 3 deaths occurring between 6 months and 1 year, with no deaths occurring subsequently. Death-censored graft survival was 82% (with 3 early graft losses and 3 graft losses between 2 and 5 years). Mean eGFR at 5 years was 50.1 (MDRD), 55.8 (CKD-EPI, 2021) and 52.5 (KRS, 2023) mL/min/1.73 m2 (N=24 patients) among functioning grafts.

Summary

Keywords

desensitization, highly sensitized patients, imlifidase, kidney transplantation, long-term follow-up

Received

13 August 2025

Accepted

28 October 2025

Copyright

© 2025 Lorant, Lonze, Montgomery, Desai, Legendre, Lundgren, von Zur Mühlen, Vo, Sjöholm, Runström, Tollemar and Jordan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Tomas Lorant, tomas.lorant@uu.se

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