End Stage Renal Disease
Conditions
Keywords
Kidney, Porcine, Xeno-Transplant
Brief 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.
Interventions
BIOLOGICALChoironeX 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.
Sponsors
Xeno Holdings (US), LLC dba ChoironeX
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival without the need for dialysis at Month 3. | 3 months |
| Graft survival free from hyperacute rejection at Day 3. | 3 Days |
| Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6. | 6 months |
| Banff classification of xenograft pathology at biopsy. | 6 months |
| Renal filtration function as assessed by creatinine clearance (CrCl) by nuclear medicine scan at Day 14, Months 1, 3, and 6. | 6 months |
| Total number of clinically significant fluid electrolyte, hemodynamic, acid-base, and hematologic abnormalities requiring medical intervention per patient through Month 6. | 6 months |
| Total number of clinically significant mineral metabolism abnormalities requiring medical intervention per patient through Month 6 | 6 months |
| Incidences of severe proteinuria (i.e., urinary protein: creatinine ratio of >3.5 g/g) per patient through Month 6. | 6 months |
| Change from baseline in blood pressure at Months 3 and 6. | 6 months |
| Incidence of porcine-derived infectious complications through Month 6, in study subjects, site staff, or close personal contacts. | 6 months |
| Incidence of opportunistic infections (excluding zoonoses) through Month 6, in study subjects. | 6 months |
| Change from baseline in thymokidney size using ultrasound imaging at Day 14, 21, and Months 1-6. | 6 months |
| New-onset diabetes after transplant (NODAT) through Month 6. | 6 months |
| Change from baseline in BMI at Months 3 and 6. | 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. | 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. | 6 months |
| Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Kidney Transplant Questionnaire. | 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. | 6 months |
| Evaluate allosensitization in recipients of the thymokidney, defined as a >20% increase from baseline in panel reactive antibody (PRA). | 6 months |
| Duration of initial hospitalization. | 6 months |
| Duration of ICU care during initial hospitalization. | 6 months |
| Number of hospitalizations through Month 6. | 6 months |
| Time to thymokidney explant, and time to restarting dialysis after explant (if relevant). | 6 months |
| Incidence of temporary dialysis treatments through Month 6. | 6 months |
| Number of dialysis-free days through Month 6. | 6 months |
| Time from transplant to first dialysis treatment (if relevant). | 6 months |
Countries
United States
Contacts
CONTACTGemma Hodgson
CONTACTAnna Danilewicz
STUDY_DIRECTORAnh Nyugen, MD
ChoironeX / Our Hybrid Concepts LLC
Outcome results
None listed