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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 70 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

4 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Xeno Holdings (US), LLC dba ChoironeX

Study start

2026-11 Estimated

Primary completion

Jun 30, 2028 Estimated

Study completion

Oct 30, 2028 Estimated

First posted

Jul 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts