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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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 Site 2
New York, New York, United States
Study Site 1
New York, New York, United States
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.
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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