EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)
United Therapeutics
Summary
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.
Description
This is a Phase 1/2/3, multicenter, open-label, safety and efficacy study of the 10 GE Xenokidney in patients with ESRD. The study will be comprised of the following: * A Screening Period up to 52 weeks. * Part A consists of the 10 GE Xenokidney transplantation followed by a 24-week Post-transplant Follow-up Period, including the evaluation of all study endpoints and safety assessments. * Part B is a Long-term Follow-up Period that extends for the lifetime of participants who received the 10 GE Xenokidney, including but not limited to documentation of participant survival, 10 GE Xenokidney su…
Eligibility
- Age range
- 40–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for all Participants (Groups 1 and 2): 1. Provide voluntarily informed consent to participate in the study and for lifetime follow up. 2. Have a diagnosis of ESRD at the time of informed consent. 3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula/graft or permanent catheter at the time of informed consent. 4. 50 to 70 years of age at the time of informed consent, or 40 to \<50 years of a age with a calculated panel reactive antibody (cPRA) of ≥99.9%. 5. Live withing 3 hours travel time of the xenotransplant center. 6. Female pa…
Interventions
- Biological10 GE Xenokidney
Porcine-derived kidney containing intentional genomic alterations for xenotransplantation
Locations (2)
- Northwestern Memorial HospitalChicago, Illinois
- New York University Langone HealthNew York, New York