Hansa Biopharma AB announced that the first patient has been treated in the PAES for Idefirix® as a desensitization treatment for highly sensitized people undergoing a kidney transplant.
This open-label Phase 3 study will enroll 50 highly sensitized adult kidney transplant patients with positive crossmatch against an available deceased donor to confirm the long-term efficacy and safety of Idefirix®. The PAES is an obligation under the conditional marketing authorization for Idefirix® granted by EMA in August 2020, in order to complete a full marketing authorization for the European Union. The PAES will enrol patients across multiple countries and centers in Europe and the study will include 50 highly sensitized and crossmatch positive patients to be treated with Idefirix®. The aim of the study is to confirm the long-term efficacy and safety of Idefirix® and the primary objective of the study is to determine the 1-year graft failure-free survival of the Idefirix® treated and transplanted patients. In addition, a total of 50-100 patients undergoing compatible kidney transplantation at the participating centers will be included and serve as a non-comparative concurrent reference cohort, with no formal comparison, to contextualize the 1-year graft failure-free survival of the Idefirix® treated patients.