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

Study acronym: EXTEND
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Mar 2029 → Nov 2029
See other at-risk trials from United Therapeutics

Record History

  1. Primary completion pushed from Mar 2029 to Nov 2029 Start date: Jun 2026 to Nov 2026 · Completion pushed from Mar 2076 to Nov 2076v4 Show 2 more changesShow less
    • Start date: Jun 2026 to Nov 2026
    • Completion pushed from Mar 2076 to Nov 2076
  2. Start date: Mar 2026 to Jun 2026v3
  3. Eligibility criteria shortened, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.
Trial Details
NCT Number NCT07224763
Lead Sponsor United Therapeutics
Conditions ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov