Hansa Biopharma recently announced that the first patient has been enrolled in its CONFIDES trial—a US pivotal, open-label, randomised controlled study—at the Columbia University Medical Center (New York, USA). The CONFIDES trial is evaluating the drug imlifidase as a potential desensitisation therapy to enable kidney transplants in highly sensitised patients waiting for a deceased donor through the US kidney allocation system.
The trial is expected to randomise 64 highly sensitised kidney transplant patients with a calculated panel reactive antibody (cPRA) of ≥99.9%, representing a subset of very highly sensitised patients that continue to be disadvantaged despite prioritisation under the US kidney allocation system, a Hansa Biopharma press release states.
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 randomised to either imlifidase desensitisation treatment or to a control arm that will receive standard of care (which involves waiting for a more compatible kidney offer or receiving an experimental desensitisation treatment).
The study’s primary endpoint for imlifidase to evaluate benefit in transplanting highly sensitised patients is kidney graft function at 12 months, measured by estimated glomerular filtration rate (eGFR).
The release adds that the goals of the CONFIDES trial are aligned with the Advancing American Kidney Health (AAKH) US executive order, which is centred around three broad goals: reducing the risk of kidney failure; improving access to and the quality of person-centred treatment options; and increasing access to kidney transplants—with the latter two directly tied to expanding transplantation.
“We are very excited about participating in this imlifidase study,” said Lloyd E Ratner, professor of Surgery and director of Renal and Pancreatic Transplantation at Columbia University. “We anxiously await the outcome of this study. Access to organ transplantation truly can make the difference between life and death. Those patients in need of kidney transplantation who are highly sensitised (i.e. immunologically incompatible with the majority of the population) have extremely limited access to transplantation and as a result imlifidase has the potential to be a total gamechanger in access to transplantation for patients with the most challenging problems.
“Preliminary data from prior studies indicate that imlifidase has the potential to eliminate the antibodies that are responsible for these immunologic incompatibilities. Thus, we are very optimistic that imlifidase may enable kidney transplantation, increase access to transplantation, improve equity, and offer renewed hope to the thousands of highly sensitised patients with end-stage renal disease.”
Robert A Montgomery, professor of Surgery and director at the NYU Langone Transplant Institute in New York City, USA, has been appointed national coordinating investigator for the CONFIDES trial.
The study will enrol patients at 12 to 15 leading transplantation centres in the USA, with completion of enrolment anticipated in the second half of 2022 and a 12-month follow-up study period set to be completed in the second half of 2023. Results from this pivotal trial are expected to support a potential Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) under the accelerated approval pathway in the first half of 2024.
Imlifidase has already received conditional marketing approval in Europe for the desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor.