Silver Spring-based United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has approved its application to start a clinical study of UKidney™, a kidney derived from a genetically modified pig.
The study will initially enroll six patients with end-stage renal disease (ESRD) and may expand to include up to 50 participants. The goal is to support a future application for a Biologics License with the FDA, according to a press release. The company plans to perform the first xenotransplant procedure in this trial around mid-2025.
As reported by Source of the Spring, United Therapeutics recently celebrated the success of its first living recipient of a UThymoKidney, who is recovering well after a transplant performed alongside a heart pump implant. This achievement builds on two successful UHeart transplants completed in 2022 and 2023.
Currently, over 557,000 patients in the U.S. rely on dialysis when their kidneys fail. United Therapeutics aims to provide an alternative to dialysis through xenotransplantation, which could help patients who are unlikely to receive a traditional kidney transplant.
Leigh Peterson, Ph.D., Executive Vice President at United Therapeutics, stated, “This clearance for our first-ever clinical trial of a xenokidney is a big step forward in our mission to increase the availability of transplantable organs and offer patients a better option than a lifetime on dialysis.”
Per the press release: This first-in-human clinical study aims to assess safety and efficacy of the UKidney in two groups of participants:
– ESRD patients who have been assessed and determined to be ineligible for a conventional allogeneic kidney transplant for medical reasons; and
– ESRD patients who have been on the kidney transplant waitlist but are more likely to die or go untransplanted than receive a deceased donor kidney transplant within five years.
“Eliminating the need for dialysis or limiting time on dialysis may improve survival for many patients with ESRD,” said Noah Byrd, Ph.D., RAC, Vice President, Global Regulatory Affairs at United Therapeutics. “We appreciate the productive collaboration with the FDA in advancing our efforts to bring this potentially revolutionary therapeutic option to the hundreds of thousands of ESRD patients.”