| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07224763 | Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD | PHASE1 | RECRUITING | 50 | — | — | Jun 1, 2026 | Mar 1, 2076 | May 27, 2026 | 1 | United States |
Participant survival rate at 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.
Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause.
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.
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.
Endogenous measured GFR (24-hour urine creatinine clearance) at 24 weeks post transplant.
Exogenous measured GFR (nuclear medicine GFR) 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.
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).
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).
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.
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 adverse events and serious adverse events; all-cause mortality.
Incidence of proteinuria from Day 0.
Incidence of zoonotic infection from Day 0.
Incidence of opportunistic infection from Day 0.
| Arm | Type | Description |
|---|---|---|
| GGTA1 KO Thymokidney | EXPERIMENTAL | Participants will receive GGTA1 KO Thymokidney |
| Name | Type | Description |
|---|---|---|
| GGTA1 KO Thymokidney | BIOLOGICAL | Porcine kidney containing an intentional genomic alteration and thymic tissue autograft for xenotransplantation |
Inclusion Criteria for all Participants (Groups 1 and 2): 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-v...