End Stage Renal DiseasePhase 1NCT07696962
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
A Phase 1 study testing ChoironeX GalKO Porcine Thymokidney in people with End Stage Renal Disease, run by Xeno Holdings (US), LLC dba ChoironeX at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- ChoironeX GalKO Porcine Thymokidney
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to 30 Sep 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Danilewicz contact
United States2 sites
Study Site 2
New York, New York, 10016
Research Coordinator
Study Site 1
New York, New York, 10032
Research Coordinator
About this study
Official title: Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
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.
- Conditions
- End Stage Renal Disease
- Being tested
- ChoironeX GalKO Porcine Thymokidney
- Keywords
- Kidney, Porcine, Xeno-Transplant
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChoironeX GalKO Porcine ThymokidneyBiological
A constructed thymokidney from a genetically modified porcine donor will be preserved, packaged, transported and transplanted into the study subject at the study site in the same fashion as a human donor kidney. The thymokidney will remain in the subject throughout the subject's lifetime, or until thymokidney explant.
| Study group | Role | What they receive |
|---|---|---|
| Porcine Thymokidney | Experimental | Porcine Thymokidney transplanted into patients with End Stage Renal Disease Receives: Biological: ChoironeX GalKO Porcine Thymokidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 6 months
Overall survival of the recipient without the need for chronic dialysis at Month 6.
Measured: 6 months
Secondary outcomes (26)
Overall survival without the need for dialysis at Month 3.
Measured: 3 months
Graft survival free from hyperacute rejection at Day 3.
Measured: 3 Days
Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6.
Measured: 6 months
Banff classification of xenograft pathology at biopsy.
Measured: 6 months
Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6.
Measured: 6 months
Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6.
Measured: 6 months
Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6
Measured: 6 months
Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6.
Measured: 6 months
Change from baseline in blood pressure at Months 3 and 6.
Measured: 6 months
Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts.
Measured: 6 months
Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects.
Measured: 6 months
Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6.
Measured: 6 months
New-onset diabetes after transplant (NODAT) through Month 6.
Measured: 6 months
Change from baseline in BMI at Months 3 and 6.
Measured: 6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the EuroQol 5-Dimension 5-Level Questionnaire.
Measured: 6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Standardized Outcomes in Nephrology Life Subject Questionnaire.
Measured: 6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Kidney Transplant Questionnaire.
Measured: 6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Patient Global Impression of Change Questionnaire.
Measured: 6 months
Evaluate allosensitization in recipients of the thymokidney, defined as a >20% increase from baseline in panel reactive antibody (PRA).
Measured: 6 months
Duration of initial hospitalization.
Measured: 6 months
Duration of ICU care during initial hospitalization.
Measured: 6 months
Number of hospitalizations through Month 6.
Measured: 6 months
Time to thymokidney explant, and time to restarting dialysis after explant (if relevant).
Measured: 6 months
Incidence of temporary dialysis treatments through Month 6.
Measured: 6 months
Number of dialysis-free days through Month 6.
Measured: 6 months
Time from transplant to first dialysis treatment (if relevant).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startSep 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xeno Holdings (US), LLC dba ChoironeX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anh Nyugen, MD, Study director, ChoironeX / Our Hybrid Concepts LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696962
- Sponsor's protocol ID
- CHX-01-101
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No