Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
← catalyst calendarNCT06878560 · readout ≤ 804 d
Sponsored by United Therapeutics (industry) · UTHR — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
50estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-29 | actual | When the study began enrolling |
| Primary completion | Oct 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2075 | estimated | The whole study's end, after follow-up |
| First posted | 2025-03-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- ESRD (End-Stage Renal Disease)
- Kidney Transplantation
- Xenotransplantation
Intervention
- Biological: 10 GE Xenokidney — also filed as Xenokidney, UKidney
Primary outcomes
what the primary-completion date above is the date OFSurvival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant
measured Day 0 (day of xenotransplantation) to 24 weeks post transplant
Survival Rate of the 10 GE Xenokidney at 24 Weeks Post Transplant
measured Day 0 (day of xenotransplantation) to 24 weeks post transplant
Survival Time of Participants Receiving the 10 GE Xenokidney
measured Day 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
Survival Time of the 10 GE Xenokidney (Overall Survival)
measured 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 xenokidney is functional, up to 50 years
Survival Time of the 10 GE Xenokidney (Death-censored Survival)
measured 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 xenokidney is functional, up to 50 years
10 GE Xenokidney Function Post Transplant (Endogenous GFR)
measured At 24 weeks post transplant
10 GE Xenokidney Function Post Transplant (Exogenous GFR)
measured At 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by EuroQol 5-Dimension 5-Level (EQ-5D-5L)
measured Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by Standardized Outcomes in Nephrology Life Participant (SONG-LP)
measured Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by Kidney Transplant Questionnaire (KTQ)
measured Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the 10 GE Xenokidney by Patient Global Impression of Change (PGI-C)
measured At 24 weeks post transplant
Incidence of Treatment-Emergent Adverse Events (Safety of the 10 GE Xenokidney)
measured Baseline until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of Proteinuria
measured Day 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of Zoonotic Infection
measured Day 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
Incidence of Opportunistic Infection
measured Day 0 (day of xenotransplantation) until last visit, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 years, or for 1 year after nephrectomy if required
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