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

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NCT07224763 · readout ≤ 955 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
1
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
DateFiledBasisWhat it is
StartJun 2026estimatedWhen the study began enrolling
Primary completionMar 2029estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionMar 2076estimatedThe whole study's end, after follow-up
First posted2025-11-05actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-27actualThe 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: GGTA1 KO Thymokidney

Primary outcomes

what the primary-completion date above is the date OF
Survival Rate of Patients with ESRD Receiving the GGTA1 KO Thymokidney at 24 Weeks Post Transplant
measured Day 0 (day of xenotransplantation) to 24 weeks post transplant
Survival Rate of the GGTA1 KO Thymokidney at 24 Weeks Post Transplant
measured Day 0 (day of xenotransplantation) to 24 weeks post transplant
Survival Time of Participants Receiving the GGTA1 KO Thymokidney
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 GGTA1 KO Thymokidney (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 thymokidney is functional, up to 50 years
Survival Time of the GGTA1 KO Thymokidney (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 thymokidney is functional, up to 50 years
GGTA1 KO Thymokidney Function Post Transplant (Endogenous GFR)
measured At 24 weeks post transplant
GGTA1 KO Thymokidney Function Post Transplant (Exogenous GFR)
measured At 24 weeks post transplant
GGTA1 KO Thymokidney Function Post Transplant (Proliferative Responsiveness)
measured At 24 weeks post transplant
Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by EuroQol 5-Dimension 5-Level (EQ-5D-5L)
measured Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by Standardized Outcomes in Nephrology Life Participant (SONG-LP)
measured Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by Kidney Transplant Questionnaire (KTQ)
measured Baseline to 24 weeks post transplant
Quality of Life in Participants Receiving the GGTA1 KO Thymokidney by Patient Global Impression of Change (PGI-C)
measured At 24 weeks post transplant
Incidence of Treatment-Emergent Adverse Events (Safety of the GGTA1 KO Thymokidney)
measured 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 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 thymokidney 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 thymokidney 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 thymokidney is functional, up to 50 years, or for 1 year after nephrectomy if required

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