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Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD

Study acronym: EXPAND
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 2v6
  2. Primary completion date: Aug 2075 to Oct 2028 Completion date: Aug 2075 to Oct 2075 · Start date changed from estimate of Aug 2025 to Oct 29, 2025 · Eligibility criteria expanded, about 26 wordsv5 Show 3 more changesShow less
    • Completion date: Aug 2075 to Oct 2075
    • Start date changed from estimate of Aug 2025 to Oct 29, 2025
    • Eligibility criteria expanded, about 26 words

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 60 wordsv4 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Eligibility criteria shortened, about 2 wordsv3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Jun 1, 2028 to Aug 2075 Start date: Jun 2025 to Aug 2025 · Primary endpoints: 13 to 15 · Eligibility criteria expanded, about 44 words · 1 morev2 Show 4 more changesShow less
    • Start date: Jun 2025 to Aug 2025
    • Primary endpoints: 13 to 15
    • Eligibility criteria expanded, about 44 words
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 10 GE Xenokidney in patients with 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, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.
Trial Details
NCT Number NCT06878560
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