Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
10 GE Xenokidney · 1 trial · 3 indications
Participant survival rate at 24 weeks post transplant.
10 GE Xenokidney survival rate at 24 weeks post transplant. 10 GE Xenokidney failure is defined as 10 GE Xenokidney nephrectomy.
Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause
Overall survival of the 10 GE Xenokidney post transplant. Overall survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney nephrectomy or death, whichever occurs first.
Death-censored survival 10 GE Xenokidney. Death-censored survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney 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.
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 |
|---|---|---|
| 10 GE Xenokidney | EXPERIMENTAL | Participants will receive 10 GE Xenokidney |
| Name | Type | Description |
|---|---|---|
| 10 GE Xenokidney | BIOLOGICAL | Porcine-derived kidney containing intentional genomic alterations 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...
10 GE Xenokidney is an investigational xenotransplantation product being studied for the treatment of end-stage renal disease (ESRD). It is intended to serve as a kidney replacement in patients with ESRD who require transplantation. The product is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
10 GE Xenokidney is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this investigational xenotransplantation product in patients with end-stage renal disease.
10 GE Xenokidney is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is currently recruiting participants in the United States to evaluate the safety and efficacy of this xenotransplantation approach for end-stage renal disease.
10 GE Xenokidney is being evaluated in a Phase 1 clinical trial registered as NCT06878560, titled "Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD." The trial is recruiting 50 participants aged 40 years and older in the United States and is currently active.
10 GE Xenokidney is a xenotransplantation product, meaning it involves transplanting a kidney from a genetically engineered pig into a human patient. The "10 GE" designation refers to the number of genetic modifications made to the donor pig to reduce the risk of organ rejection and improve compatibility with the human recipient.