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

Starting soon · Phase 1

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT07696962

Run by

Xeno Holdings (US), LLC dba ChoironeX

People needed

4

Starts

2026-07-01

Expected to finish

2028-09-30

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study Site 2 — New York, New York, United States
• Study Site 1 — New York, New York, United States

Full record on ClinicalTrials.gov

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