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

Xeno Holdings (US), LLC dba ChoironeX

Status and phase

Not yet enrolling

Phase 1

Conditions

End Stage Renal Disease

Treatments

Biological: ChoironeX GalKO Porcine Thymokidney

Study type

Interventional

Funder types

Industry

Identifiers

NCT07696962

CHX-01-101

Details and patient eligibility

About

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.

Enrollment

4 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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