Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease (NCT07696962) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
United States4 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.
Timeframe: 6 months
2
Overall survival of the recipient without the need for chronic dialysis at Month 6.