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

Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease

The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with 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