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).
The goals of the ConfIdeS trial are aligned with the “Advancing American Kidney Health” (“AAKH”) U.S. Executive Order (https://kidney360.asnjournals.org/content/1/6/557), which is centered around three broad goals: (1) reducing the risk of kidney failure; (2) improving access to and the quality of person-centered treatment options; and (3) increasing access to kidney transplants, with the latter two directly tied to expanding transplantation.
Robert A. Montgomery, M.D., Professor of Surgery and Director, NYU Langone Transplant Institute in New York City, has been appointed National Coordinating Investigator for the ConfIdeS trial. The trial will enroll patients at 12 to 15 leading transplantation centers in the U.S.
Completion of enrollment in the trial is expected in the second half of 2022, with a 12-month follow-up study period expected to be completed in the second half of 2023. Results from this pivotal trial are expected to support a potential BLA submission to the FDA under the accelerated approval pathway in the first half of 2024.
Imlifidase has already received conditional marketing approval in Europe for the desensitization treatment of highly sensitized adult kidney transplant patients with positive crossmatch against an available deceased donor.
