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A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF INTRAVENOUS IDES AFTER ADMINISTRATION OF ASCENDING DOSES IN CHRONIC KIDNEY DISEASE PATIENTS

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Trial Profile

A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF INTRAVENOUS IDES AFTER ADMINISTRATION OF ASCENDING DOSES IN CHRONIC KIDNEY DISEASE PATIENTS

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 Registrational; Therapeutic Use
  • 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.
    • 27 Dec 2021 Results of Sera from HLA-sensitized patients with CKD deriving from NCT02224820 assessing o investigate F--mediated effector functions of scIgG and its potential impact oncommon clinical immunologic assays used to assess transplant eligibility.published in the 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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