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RECRUITING

NCT07696962

PHASE1

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

Sponsor: Xeno Holdings (US), LLC dba ChoironeX

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2028-10-30

Last Updated

2026-11-02

Healthy Volunteers

Conditions

End Stage Renal Disease

Interventions

BIOLOGICAL

ChoironeX GalKO Porcine Thymokidney

A constructed thymokidney from a genetically modified porcine donor will be preserved, packaged, transported and transplanted into the study subject at the study site in the same fashion as a human donor kidney. The thymokidney will remain in the subject throughout the subject's lifetime, or until thymokidney explant.

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

Locations (2)

NYU Langone Health

New York, New York, United States

Study Site 2