Transplant Surgery Research Program Brings New Hope with Participation in Groundbreaking Clinical Trial

The Froedtert & MCW Transplant Research Program has enrolled multiple patients in the ConfIdeS trial, which is led by Dr. Matthew Cooper, site principal investigator and chief of the division of transplant surgery. This pivotal trial is conducted by Hansa Biopharma AB and evaluates 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 study team, including Dr. Ty Dunn, professor of surgery, and James Zelten, clinical research manager, played an instrumental role in making this significant achievement possible. Their combined efforts underscore the capability and dedication of our transplant surgery program to participate in groundbreaking studies that offer new hope to patients in need.

"We are thrilled to bring this innovative treatment option to our patients at Froedtert & MCW," said Dr. Cooper. "The ConfIdeS trial represents a crucial step forward in addressing the unmet medical needs of highly sensitized patients who face significant barriers to kidney transplantation."

The ConfIdeS trial aims to randomize 64 highly sensitized kidney transplant patients with a cPRA of ≥99.9%, representing those who are most disadvantaged despite prioritization under the U.S. kidney allocation system. Patients will be randomized to either receive Imlifidase desensitization treatment or a control arm that provides standard care. The primary endpoint of the study is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate).

This trial aligns with the goals of the "Advancing American Kidney Health" (AAKH) U.S. Executive Order, which focuses on reducing the risk of kidney failure, improving access to quality person-centered treatment options, and increasing access to kidney transplants.

"We are excited to participate in this crucial study," said Dr. Ty Dunn. "Imlifidase has the potential to be a transformative therapy, expanding access to kidney transplants for highly sensitized patients who otherwise have extremely limited options."

The enrollment of the first two patients in the ConfIdeS trial marks a significant milestone for Froedtert & MCW. It highlights the team’s commitment to advancing medical research and providing innovative treatment options to improve patient outcomes.

For more information about the ConfIdeS trial and the role of Froedtert & MCW in advancing kidney transplantation research, please contact the transplant surgery program.