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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
United Therapeutics
Study ID
NCT06878560
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • ESRD (End-Stage Renal Disease)
  • Kidney Transplantation
  • Xenotransplantation

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 10 GE Xenokidney — BIOLOGICAL
    Porcine-derived kidney containing intentional genomic alterations for xenotransplantation

Study Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2075

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 10 GE Xenokidney
    Participants will receive 10 GE Xenokidney

Primary Outcome Measure

Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant [ Time Frame: Day 0 (day of xenotransplantation) to 24 weeks post transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Michelle Callegari
[email protected]
Satish N Nadig, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR)
New York University Langone HealthNew YorkNew York10016
Karen Khalil
[email protected]
347-514-2758
Robert A Montgomery, MD, DPhil (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Northwestern Memorial Hospital· Chicago, ILNew York University Langone Health· New York, NY

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