Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
brief summary
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.
detailed description
This is a Phase 1/2/3, multicenter, open-label, safety and efficacy study of the 10 GE Xenokidney in patients with ESRD. The study will be comprised of the following:
* A Screening Period up to 52 weeks. * Part A consists of the 10 GE Xenokidney transplantation followed by a 24-week Post-transplant Follow-up Period, including the evaluation of all study endpoints and safety assessments. * Part B is a Long-term Follow-up Period that extends for the lifetime of participants who received the 10 GE Xenokidney, including but not limited to documentation of participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections.
There will be 2 groups of participants enrolled in the study. Group 1 will be participants deemed ineligible for conventional allogeneic kidney transplantation due to medical reason(s). Group 2 will be participants on an OPTN kidney transplant waitlist but are more likely to die or go untransplanted within 5 years than receive a kidney transplant.
official title
EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)