Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD

The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.

NCT Number	NCT06878560
Lead Sponsor	United Therapeutics
Conditions	ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
Enrollment	50 participants
Start Date	2025-10-29
Primary Completion	2028-10 (estimated)
Study Completion	2075-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-27