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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
10 GE Xenokidney
Biological/VaccinePorcine-derived kidney containing intentional genomic alterations for xenotransplantation
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 10 GE XenokidneyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post Transplant
Participant survival rate at 24 weeks post transplant.
Time frame
Day 0 (day of xenotransplantation) to 24 weeks post transplant2
Survival Rate of the 10 GE Xenokidney at 24 Weeks Post Transplant
10 GE Xenokidney survival rate at 24 weeks post transplant. 10 GE Xenokidney failure is defined as 10 GE Xenokidney nephrectomy.
Time frame
Day 0 (day of xenotransplantation) to 24 weeks post transplant3
Survival Time of Participants Receiving the 10 GE Xenokidney
Participant survival post transplant. Participant survival is defined as time from xenotransplantation to death for any cause
Time frame
Day 0 (day of xenotransplantation) until death for any cause, assessed at least every 24 weeks after transplantation while the participant is alive, up to 50 years4
Survival Time of the 10 GE Xenokidney (Overall Survival)
Overall survival of the 10 GE Xenokidney post transplant. Overall survival time of the 10 GE Xenokidney is defined as time from xenotransplantation to 10 GE Xenokidney nephrectomy or death, whichever occurs first.
Time frame
Day 0 (day of xenotransplantation) until start of chronic dialysis, nephrectomy, or death, whichever occurs first, assessed at least every 24 weeks after transplantation while the participant is alive and the xenokidney is functional, up to 50 yearsSponsors and contacts
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Source ClinicalTrials.gov