End-Stage Kidney Disease
Conditions
Interventions
gene-edited pig kidney transplantation:The multigene-edited porcine kidney was transplanted into the recipient's right iliac fossa, with the renal artery and vein anastomosed to the recipient's right
Sponsors
The First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To participate in the clinical study, patients must meet at least 7 of the following inclusion criteria (criteria 1, 2, 3, 4, 5, and 6 are mandatory) and must not meet any of the exclusion criteria. Inclusion Criteria: 1. Aged 18 to 75 years, regardless of gender. 2. Body Mass Index (BMI) between 18 and 35 kg/m². 3. Diagnosed with End-Stage Renal Disease (ESRD) and currently undergoing hemodialysis or peritoneal dialysis. 4. Both the participant and their immediate family members (parents, spouse, adult children) agree to participate in the study and voluntarily sign the informed consent form. 5. Compatible crossmatch with the donor pig. 6. Must undergo a psychiatric and psychological evaluation prior to trial participation; enrollment is permitted only after psychiatric or psychological disorders are ruled out. 7. High risk of mortality while waiting for a human allograft kidney within the next 5 years. 8. Patient of advanced age with a low likelihood of receiving a human allograft kidney in the transplant allocation system. 9. Low likelihood of receiving a human allograft kidney within the next 5 years after registration for transplantation. 10. Highly sensitized patient. 11. Previous kidney transplant recipient with graft failure who is not a suitable candidate for another human allograft kidney transplant. 12. Development of multiple complications during hemodialysis or peritoneal dialysis that make continued dialysis unsustainable for maintaining life. 13. Resides within a 90-minute ground transport travel time from Xijing Hospital. 14. Any other circumstances that make the patient unsuitable for human allograft kidney transplantation.
Exclusion criteria
Exclusion criteria: 1. Conditions affecting systemic immune function, such as HIV infection, diagnosed systemic immune diseases, malignancies, or current use of systemically administered corticosteroids or other immunosuppressants. 2. Intolerance to immunosuppressive medications. 3. Current pregnancy. 4. Presence of a hypercoagulable state. 5. Inability to receive blood transfusions. 6. History of medical non-compliance. 7. Untreated psychiatric disorders, such as depression or bipolar disorder. 8. Current use/abuse of illicit drugs and/or alcohol abuse. 9. History of psychiatric hospitalization. 10. Inability to accept a porcine-derived organ for religious, ethnic, or other reasons. 11. Participation in another drug clinical trial within 3 months prior to enrollment. 12. Presence of lesions at the intended transplant site that preclude surgery. 13. Severe comorbidities, including but not limited to uncontrolled hypertension or diabetes, advanced cardiovascular disease, or chronic lung disease. 14. Severe organ failure (other than renal failure), severe infection, or severe systemic illness that would preclude maintaining a transplant status. 15. Patient requiring multi-organ transplantation. 16. Patients with limited comprehension, cognitive impairment, or lack of civil capacity. 17. Inability to undergo regular and lifelong follow-up after surgery. 18. Failure to administer meningococcal vaccination to patients who are to receive eculizumab treatment. 19. Any other reason deemed by the investigator to make the patient unsuitable for participation in this study. Note: If a participant's condition changes between screening and surgery, meeting any of the exclusion criteria, they should be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft and Recipient Survival Rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Kidney Graft Function.;Immunological Rejection Control;Immunosuppressant Exposure Level; | — |
Countries
China
Contacts
Public ContactQin Weijun
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed