NCT07696962RecruitingPhase 1
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- First submitted
- 28 May 2026
- Start date
- Oct 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Xeno Holdings (US), LLC dba ChoironeX
- Diseases
- Chronic kidney disease
- NCT number
- NCT07696962
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 4
- From Oct 2026 to the primary completion date, 30 Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement for multi-organ transplantation
- Polycystic kidney disease without prior native nephrectomy
- Current drug or alcohol misuse
- 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
Other illness
- Kidney disease with high risk of post-transplant recurrence
- History of non-adherence to medical treatment
- Significant uncontrolled psychiatric illness
- Serious non-renal illness with life expectancy \<1 year
- 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
- Active infection at time of transplantation
- Positive serology for hepatitis B, hepatitis C, or HIV
- Current, active, or untreated tuberculosis
- Known severe hypersensitivity to a required study medication with no acceptable alternative
Lab values
- Diabetes mellitus with poor glycemic control (HbA1c \>10%)
Other
- Living donor available who is ABO-incompatible
- Unable or unwilling to comply with study procedures
- Identified as vulnerable by psychological assessment
- Inadequate social support or caregiver unavailable/unwilling
- BMI \<16 or \>35 kg/m²
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| - Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.