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An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC

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Trial Profile

An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2024

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At a glance

  • Drugs Imlifidase (Primary) ; Eculizumab; Immune globulin; Rituximab
  • Indications Renal transplant rejection
  • Focus Pharmacokinetics; Registrational
  • Acronyms ConfIdeS
  • Sponsors Hansa Biopharma AB
  • Most Recent Events

    • 31 May 2024 According to a Hansa Biopharma media release, recruitment and randomization in its US ConfIdeS trial is complete
    • 31 May 2024 According to a Hansa Biopharma media release, data from the trial is expected to support a Biologic License Application (BLA) submission under the accelerated approval pathway to the US Food and Drug Administration (FDA) in the second half of 2025.
    • 31 May 2024 Status changed from recruiting to active, no longer recruiting as per Hansa Biopharma media release
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