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Randomized, controlled clinical study of Imlifidase in a limited group of highly sensitized kidney patients using a surrogate endpoint.

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Trial Profile

Randomized, controlled clinical study of Imlifidase in a limited group of highly sensitized kidney patients using a surrogate endpoint.

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2021

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At a glance

  • Drugs Imlifidase (Primary)
  • Indications Renal transplant rejection
  • Focus Therapeutic Use

Most Recent Events

  • 22 Apr 2021 According to a Hansa Biopharma AB media release, the company continues to be in productive dialogue with the FDA and expects to reach an agreement near-term with the Agency on the protocol for this study. The company expects to initiate the trial over summer and to recruit the first patient in the second half of 2021. The company expects to complete enrolment in this study in H2 2022 and 12 months follow-up data is expected in H2 2023. BLA submission based on this study is expected in H1 2024.
  • 22 Oct 2020 According to a Hansa Biopharma AB media release, first patient dosing is expected in H1 2021.
  • 22 Oct 2020 According to a Hansa Biopharma AB media release, In the US, the proposed study protocol for a randomised controlled trial (RCT) targeting highly-sensitized kidney patients was submitted to the FDA in June, 2020. Discussions are currently ongoing with the FDA and, once the final protocol has been agreed upon, we will proceed to set up centers in the US and start to enroll patients.

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