A Phase 1 interventional study of ChoironeX GalKO Porcine Thymokidney in End Stage Renal Disease, sponsored by Xeno Holdings (US), LLC dba ChoironeX. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Xeno Holdings (US), LLC dba ChoironeX · Phase 1, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 4 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →This is the only study on the registry with Xeno Holdings (US), LLC dba ChoironeX as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Porcine Thymokidney transplanted into patients with End Stage Renal Disease
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.
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
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
New-onset diabetes after transplant (NODAT) through Month 6.
Time frame: 6 months
Change from baseline in BMI at Months 3 and 6.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Change from baseline in subject-reported quality of life at Months 1, 3, and 6 based on the Kidney Transplant Questionnaire.
Time frame: 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.
Time frame: 6 months
Evaluate allosensitization in recipients of the thymokidney, defined as a >20% increase from baseline in panel reactive antibody (PRA).
Time frame: 6 months
Duration of initial hospitalization.
Time frame: 6 months
Duration of ICU care during initial hospitalization.
Time frame: 6 months
Number of hospitalizations through Month 6.
Time frame: 6 months
Time to thymokidney explant, and time to restarting dialysis after explant (if relevant).
Time frame: 6 months
Incidence of temporary dialysis treatments through Month 6.
Time frame: 6 months
Number of dialysis-free days through Month 6.
Time frame: 6 months
Time from transplant to first dialysis treatment (if relevant).
Time frame: 6 months
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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