Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
Recruiting now · Phase 1/Phase 2
Conditions studied: ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
In brief
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.
Key facts
- Study ID
- NCT06878560
- Run by
- United Therapeutics
- People needed
- 50
- Starts
- 2025-10-29
- Expected to finish
- 2075-10-01
- Last updated by the study team
- 2026-03-27
Who can join
Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
- New York University Langone Health — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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