What this trial measures

• Survival Rate of Patients with ESRD Receiving the GGTA1 KO Thymokidney at 24 Weeks Post TransplantDay 0 (day of xenotransplantation) to 24 weeks post transplant

  Participant survival rate at 24 weeks post transplant.

• Survival Rate of the GGTA1 KO Thymokidney at 24 Weeks Post TransplantDay 0 (day of xenotransplantation) to 24 weeks post transplant

  GGTA1 KO Thymokidney survival rate at 24 weeks post transplant. GGTA1 KO Thymokidney failure is defined as GGTA1 KO Thymokidney nephrectomy.

• Survival Time of Participants Receiving the GGTA1 KO ThymokidneyDay 0 (day of xenotransplantation) until death for any cause, assessed at least every 24 weeks after transplantation while the participant is alive, up to 50 years

  Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause.

• Survival Time of the GGTA1 KO Thymokidney (Overall Survival)Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the thymokidney is functional, up to 50 years

  Overall survival of the GGTA1 KO Thymokidney post transplant. Overall survival time of the GGTA1 KO Thymokidney is defined as time from xenotransplantation to GGTA1 KO Thymokidney nephrectomy or death, whichever occurs first.

• Survival Time of the GGTA1 KO Thymokidney (Death-censored Survival)Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the thymokidney is functional, up to 50 years

  Death-censored survival GGTA1 KO Thymokidney. Death-censored survival time of the GGTA1 KO Thymokidney is defined as time from xenotransplantation to GGTA1 KO Thymokidney nephrectomy censored for death.

• GGTA1 KO Thymokidney Function Post Transplant (Endogenous GFR)At 24 weeks post transplant

  Endogenous measured GFR (24-hour urine creatinine clearance) at 24 weeks post transplant.

• GGTA1 KO Thymokidney Function Post Transplant (Exogenous GFR)At 24 weeks post transplant

  Exogenous measured GFR (nuclear medicine GFR) at 24 weeks post transplant.

• GGTA1 KO Thymokidney Function Post Transplant (Proliferative Responsiveness)At 24 weeks post transplant

  Proliferative responsiveness to source GGTA1 KO Pig versus third-party pig as measured by mixed lymphocyte reaction from baseline to 24 weeks post transplant.

• Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by EuroQol 5-Dimension 5-Level (EQ-5D-5L)Baseline to 24 weeks post transplant

  Change in the EQ-5D-5L from baseline to 24 weeks post transplant. The EQ-5D-5L questionnaire assesses health-related quality of life across 5 categories (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression). Each category has 5 levels, ranging from 1 (no problems) to 5 (extreme problems or inability to perform the activity). Higher scores indicate a worse health outcome (more mobility issues, greater pain, more anxiety, etc).

• Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by Standardized Outcomes in Nephrology Life Participant (SONG-LP)Baseline to 24 weeks post transplant

  Change in SONG-LP from baseline to 24 weeks post transplant. The SONG-LP assesses participation in different life activities over the past month. The minimum score (worst outcome) is 4 (if all responses are "1" - Never) and the maximum score (best outcome) is 20 (if all responses are "5" - Always). Higher scores indicate a better health outcome (greater ability to participate in activities).

• Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by Kidney Transplant Questionnaire (KTQ)Baseline to 24 weeks post transplant

  Change in KTQ from baseline to 24 weeks post transplant. Each question in the KTQ is scored on a 1 to 7 scale with: 1 = worst outcome (eg, "A very great deal of trouble or distress" / "All of the time") and 7 = best outcome (eg, "No trouble or distress" / "None of the time"). Higher scores indicate a better outcome, meaning less distress, fewer symptoms, and better well-being.

• Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by Patient Global Impression of Change (PGI-C)At 24 weeks post transplant

  PGI-C at 24 weeks post transplant. The PGI-C assesses a patient's perception of improvement or worsening over time. The minimum score (best outcome) is 1 ("Very Much Improved") and the maximum score (worst outcome) is 7 ("Very Much Worse"). Higher scores indicate a worse health outcome (greater worsening).

• Incidence of Treatment-Emergent Adverse Events (Safety of the GGTA1 KO Thymokidney)Baseline until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the thymokidney is functional, up to 50 years, or for 1 year after nephrectomy if required

  Incidence of adverse events and serious adverse events; all-cause mortality.

• Incidence of ProteinuriaDay 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the thymokidney is functional, up to 50 years, or for 1 year after nephrectomy if required

  Incidence of proteinuria from Day 0.

• Incidence of Zoonotic InfectionDay 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the thymokidney is functional, up to 50 years, or for 1 year after nephrectomy if required

  Incidence of zoonotic infection from Day 0.

• Incidence of Opportunistic InfectionDay 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the thymokidney is functional, up to 50 years, or for 1 year after nephrectomy if required

  Incidence of opportunistic infection from Day 0.