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

This study is testing a new treatment called ChoironeX GalKO Porcine Thymokidney for people with end-stage renal disease (ESRD), which means your kidneys have failed. This treatment involves transplanting a specially modified pig kidney into your body, similar to a human kidney transplant. The main goal is to see if this transplanted pig kidney can help you live without needing dialysis for at least six months. Researchers will also be carefully watching for any side effects or problems. You might be able to join if you are between 18 and 70 years old, have been on dialysis for at least six months, and are eligible for a kidney transplant but have a low chance of getting a human donor kidney soon. The study is planning to enroll 4 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 4 participants. It is not specified if it is randomized or blinded.
What's involved
The ChoironeX GalKO Porcine Thymokidney will be transplanted and will remain in your body for your lifetime, or until certain events occur. Researchers will monitor for adverse events for six months.
Compensation
Not stated in the trial record.
Follow-up
Your survival without the need for chronic dialysis will be measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07696962

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

Not Yet Recruiting
PHASE1Ages 18–70InterventionalTreatment
Xeno Holdings (US), LLC dba ChoironeX
~4 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:ChoironeX GalKO Porcine Thymokidney

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.
Measured over 6 months
+1 more outcome measured

Conditions

End Stage Renal Disease

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NCT07696962

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Study Site 1

    New York, New Yorkno site contact published

  • Study Site 2

    New York, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anh Nyugen, MD · STUDY_DIRECTOR · ChoironeX / Our Hybrid Concepts LLC

Who to contact

Gemma Hodgson
[email protected]
443-842-0861
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.6 months
  • Overall survival of the recipient without the need for chronic dialysis at Month 6.6 months