A prospective long-term confirmatory follow up trial in highly sensitized patients treated with imlifidase or standard of care in the ConfIdeS (20-HMedIdeS-17) trial

Brief description of study

A controlled, randomized, efficacy Phase 3 trial (ConfIdeS, 20-MedIdeS-17) comparing imlifidase with standard of care (SoC) in enabling highly sensitized patients to kidney transplantation is performed by Hansa Biopharma to support an Accelerated Marketing Approval of imlifidase. The present trial is a confirmatory long-term follow-up of patients participating in the ConfIdeS trial intended to gather information on clinical endpoints representing a meaningful clinical benefit i.e., patient and graft survival, and graft function, on a long-term basis (2-5 years after randomization in the ConfIdeS trial), and to confirm the positive benefit-risk balance of imlifidase.

Clinical Study Identifier: s22-01315

Principal Investigator: Bonnie Elizabeth Lonze.

Other Investigators: Rebecca Anne Esker, Robert Montgomery, Aprajita Mattoo, Bruce E Gelb, Elaina Weldon, Irfana Soomro, Jonathan C Berger, Nicole M Ali, Pablo Loarte-Campos, Vasishta Tatapudi.

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