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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Porcine Thymokidney | Experimental | Porcine Thymokidney transplanted into patients with End Stage Renal Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChoironeX GalKO Porcine Thymokidney | Biological | 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. |
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsey Dickerson | Contact | +1 (347) 602-0721 | ldickerson@nefro-avillion.com | |
| Gemma Hodgson | Contact | ghodgson@nefro-avillion.com |
| Name | Affiliation | Role |
|---|---|---|
| Anh Nyugen, MD | ChoironeX / Our Hybrid Concepts LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 2 | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| 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 |
| Study Site 1 | New York | New York | 10032 | United States |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |