Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease

Inclusion Criteria

* ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months
* Eligible for kidney transplantation per site criteria
* \<50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months
* Blood type and immunologic compatibility with study transplant confirmed by testing
* EBV seropositive
* Up to date on recommended vaccinations for immunocompromised individuals
* Willing to use protocol-required contraception
* Able to provide informed consent and comply with lifelong follow-up

Exclusion Criteria:

* Requirement for multi-organ transplantation
* Living donor available who is ABO-incompatible
* Kidney disease with high risk of post-transplant recurrence
* Polycystic kidney disease without prior native nephrectomy
* Unable or unwilling to comply with study procedures
* History of non-adherence to medical treatment
* Identified as vulnerable by psychological assessment
* Significant uncontrolled psychiatric illness
* Inadequate social support or caregiver unavailable/unwilling
* Current drug or alcohol misuse
* Serious non-renal illness with life expectancy \<1 year
* BMI \<16 or \>35 kg/m²
* Known hypercoagulable disorder
* Uncontrolled hypertension or hemodynamic instability at enrollment
* Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant arrhythmia requiring treatment
* Serious liver disease or impaired liver function
* Diabetes mellitus with poor glycemic control (HbA1c \>10%)
* Active infection at time of transplantation
* Positive serology for hepatitis B, hepatitis C, or HIV
* Current, active, or untreated tuberculosis
* Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer
* Current systemic immunosuppressive therapy (excluding permitted corticosteroids)
* Participation in another interventional drug trial within 60 days prior to enrollment
* Pregnant or breastfeeding
* Known severe hypersensitivity to a required study medication with no acceptable alternative