Not yet recruiting NCT07696962
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ChoironeX GalKO Porcine Thymokidney.
- Who it may be relevant to
- Registry conditions: End Stage Renal Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
Overview
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.
Interventions
- Biological ChoironeX GalKO Porcine Thymokidney
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.
Primary outcome 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. [Time frame: 6 months]
- Overall survival of the recipient without the need for chronic dialysis at Month 6. [Time frame: 6 months]
Secondary outcome measures (12)
- Overall survival without the need for dialysis at Month 3. [Time frame: 3 months]
- Graft survival free from hyperacute rejection at Day 3. [Time frame: 3 Days]
- Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6. [Time frame: 6 months]
- Banff classification of xenograft pathology at biopsy. [Time frame: 6 months]
- Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6. [Time frame: 6 months]
- Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6. [Time frame: 6 months]
- Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6 [Time frame: 6 months]
- Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6. [Time frame: 6 months]
- Change from baseline in blood pressure at Months 3 and 6. [Time frame: 6 months]
- Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts. [Time frame: 6 months]
- Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects. [Time frame: 6 months]
- Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6. [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Study Site 2 — New York
- Study Site 1 — New York
Identifiers
NCT: NCT07696962 · CHX-01-101