Actively Recruiting
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
Led by United Therapeutics · Updated on 2026-03-27
50
Participants Needed
2
Research Sites
2604 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary informed consent for study participation and lifetime follow-up.
- Have a diagnosis of end-stage renal disease (ESRD) at consent.
- Be hemodialysis dependent for at least 6 months with a functioning fistula, graft, or permanent catheter.
- Be aged 50 to 70 years, or aged 40 to under 50 years with a calculated panel reactive antibody (cPRA) of 99.9% or higher.
- Live within 3 hours travel time of the xenotransplant center.
- Female participants must be postmenopausal or permanently sterilized; male participants must agree to use highly effective birth control if conception is possible.
- Have a negative xeno-crossmatch at screening and pre-transplant.
- Have an estimated post-transplant survival calculator score greater than 20%.
- Have a body mass index of 35 kg/m2 or less.
- Have completed or plan to complete recommended age and risk factor appropriate vaccinations including meningococcal vaccines.
- Be seropositive for cytomegalovirus and Epstein-Barr virus.
- For Group 1: Be ineligible for conventional allogeneic kidney transplantation due to medical reasons including ineligibility for living donor transplant, OPTN waitlist ineligibility, or delisting.
- For Group 2: Be on an OPTN kidney transplant waitlist with no approved living donors and be more likely to die or remain untransplanted within 5 years than receive a transplant as measured by the Kidney Transplant Decision Aid.
You will not qualify if you...
- Need for multiple organ transplants.
- Have severe medical conditions such as chronic liver disease, advanced cardiovascular disease, severe peripheral vascular disease limiting transplant technical ability, severe neurological diseases, oral steroid-dependent airway disorders or chronic pulmonary disease requiring oxygen, pulmonary hypertension, uncontrolled diabetes or severe diabetic complications, or severe neurogenic bladder requiring intermittent catheterization.
- Have ESRD due to hereditary or structural kidney disease.
- Have active or recently treated cancer at consent.
- Have non-renal hematological disorders causing anemia like thalassemia or sickle disease.
- Cannot stop chronic anticoagulation therapy (low-dose aspirin allowed).
- Have a history of major psychiatric disorders with hospitalization or suicidal ideation within 5 years.
- Are being treated for active tuberculosis, received prophylaxis for positive TB test, or tested positive for TB during screening.
- Test positive for hepatitis B or C virus, have low hepatitis B surface antibody titers unless nonresponder to vaccination, or test positive for HIV.
- Are unable to perform daily activities independently.
- Have a history of medical noncompliance that may affect adherence, including recent substance use disorder, lack of social support, or untreated psychological conditions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
2
New York University Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
U
United Therapeutics Global Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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