Porcine thymokidney transplant for end-stage renal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial to assess the safety and feasibility of transplanting a GalKO porcine thymokidney (ChoironeX) into adults with end-stage renal disease. Eligible participants have been on dialysis for at least six months and meet transplant criteria but have a low chance of receiving a deceased-donor kidney within a year. The study examines whether the xenotransplant can maintain renal function and reduce or eliminate dialysis dependence, under protocol-mandated follow-up. Participants must be EBV seropositive, up to date on vaccines, and compliant with long-term monitoring. Primary outcomes focus on safety and renal function preservation, with ancillary measures of immunologic compatibility and transplantation-related complications.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• Study Site 2
  New York, New York, United States Not yet recruiting

Study contacts

• Study coordinator: Gemma Hodgson
• Email: ghodgson@xeno-holdings.com
• Phone: 443-842-0861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.