Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-70
SponsorUnited Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
Provide voluntarily informed consent to participate in the study and for lifetime follow up.
Have a diagnosis of ESRD at the time of informed consent.
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.
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%.
Disqualifiers
Need for multiple organ transplants.
Chronic liver disease.
Advanced cardiovascular disease.
Severe peripheral vascular disease that limits technical ability to transplant the 10 GE Xenokidney.
Trial design
Treatments tested in this trial
- 10 GE Xenokidney
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov