Hansa Biopharma AB (publ) announces that the first patient in its U.S. open-label, randomized, controlled pivotal trial ("ConfIdeS") has been enrolled at the Columbia University Medical Center, New York. The ConfIdeS trial is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. The trial is expected to randomize 64 highly sensitized kidney transplant patients with a cPRA of =99.9%, representing a subset of very highly sensitized patients that continue to be disadvantaged despite prioritization under the U.S. kidney allocation system. When a donor organ becomes available and a positive crossmatch with the intended recipient indicates that the organ is not compatible, the patient will be randomized to either imlifidase desensitization treatment or to a control arm that will receive standard of care (i.e. waiting for a more compatible kidney offer or receiving an experimental desensitization treatment). The study's primary endpoint for imlifidase to evaluate benefit in transplanting highly sensitized patients is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate).