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A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation

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Trial Profile

A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jul 2023

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At a glance

  • Drugs Imlifidase (Primary)
  • Indications Renal transplant rejection
  • Focus Adverse reactions; Registrational
  • Sponsors Hansa Biopharma AB; Hansa Medical AB

    • Most Recent Events

    • 11 Jul 2023 According to a Hansa Biopharma AB media release, the Australian Therapeutic Goods Administration ("TGA") has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors. The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies.
    • 01 Sep 2021 Results assessing patterns and timing of rebound for anti-drug antibodies IgG presented at the 20th Congress of the European Society for Organ Transplantation
    • 08 Jul 2021 Results of pooled analysis assessing 3 years post transplant from 13 HMedIdeS02, 13HMedIdeS03, 14HMedIdeS04 15HMedIdeS06 and 17HMedIdeS14 published in the American Journal of Transplantation.
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