Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Inclusion Criteria

• •1. Provide voluntarily informed consent to participate in the study and for lifetime follow-up.
• •2. Have a diagnosis of ESRD at the time of informed consent.
• •3. 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.
• •4. 50 to 70 years of age at the time of informed consent, or 40 to \<50 years of age with a calculated panel reactive antibody (cPRA) of ≥99.9%.
• •5. Evidence of thymic involution on chest computed tomography (CT) scan with a thymic region of interest score of ≤1.
• •6. Live within 3 hours travel time of the xenotransplant center.
• •7. 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.
• •8. Negative xeno-crossmatch at Screening and pre-transplant.
• •9. Estimated Post Transplant Survival Calculator score \>20%.(https://optn.transplant.hrsa.gov/data/allocation-calculators/epts-calculator/).
• •10. Body mass index ≤35 kg/m2.
• •11. 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.
• •12. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.
• •1\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:
• •1. Ineligible for a living donor transplant.
• •2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).
• •3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).
• •1. On an OPTN kidney transplant waitlist (active or inactive status).
• •2. No approved living kidney donors.
• •3. 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/).