EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (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.
• Provide voluntarily informed consent to participate in the study and for lifetime follow up.
• Have a diagnosis of ESRD at the time of informed consent.
• Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula/graft or permanent catheter at the time of informed consent.
• 55 to 70 years of age at the time of informed consent.
• Live withing 3 hours travel time of the xenotransplant center.
• Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.
• Negative xeno-crossmatch at Screening and Day -1.
• Estimated Post Transplant Survival Calculator score \>20% (https://optn.transplant.hrsa.gov/data/allocation-calculators/epts-calculator/).
• Body mass index ≤35 kg/m2.
⁃ Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention recommended courses of age and risk factor appropriate vaccinations.
⁃ Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.
‣ Additional Inclusion Criteria for Group 1:
‣ 1\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:
• Ineligible for a living donor transplant.
• Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).
• Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).
‣ Additional Inclusion Criteria for Group 2:
• On an active OPTN kidney transplant waitlist.
• No approved living kidney donors.
• More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for Choose your state field and National average for Choose your transplant program field; https://www.srtr.org/tools/kidney-transplant-decision-aid/).