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.
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
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
Single group
ChoironeX GalKO Porcine Thymokidney
Biological/VaccineA 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.
Overall survival of the recipient without the need for chronic dialysis at Month 6.
Overall survival without the need for dialysis at Month 3.
Graft survival free from hyperacute rejection at Day 3.
Incidence of acute and chronic xenograft rejection at Day 14, Months 3 and 6.
Banff classification of xenograft pathology at biopsy.
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This trial is not recruiting at the moment. You can still explore other options:
