End-stage renal disease (CKD5)
Conditions
Interventions
Experimental Group:Xenotransplantation of genetically modified pig kidneys into humans
Sponsors
The Second Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 25–65 years, male or female. 2. Confirmed diagnosis of chronic kidney disease stage 5, dependent on regular renal replacement therapy (hemodialysis or peritoneal dialysis). 1.or almost unable to obtain a matched human donor kidney due to high sensitization (high population reactivity antibodies), impending loss of dialysis access, or failure of a previous transplant due to relapse of the primary disease; 3. Completion of routine evaluation for allogeneic kidney transplantation, with confirmation by the study's multidisciplinary assessment team that, within the foreseeable future, there is no realistic access to a human donor kidney, or, even if theoretically eligible for waiting, the feasibility of conventional allogeneic kidney transplantation is extremely low due to factors such as high sensitization, repeated transplant failure, or impending loss of dialysis access. 4. Cardiac, hepatic, pulmonary, and other vital organ functions assessed as sufficient to tolerate the transplant surgery and intensive postoperative monitoring. 5. Possesses full civil capacity, is able to understand the nature of the study, potential benefits and risks, long-term follow-up requirements, and public health management requirements, and can independently sign the written informed consent form. In accordance with ethical review requirements, a close relative may participate in the informed consent process and sign as a witness. 6. Willing to comply with postoperative long-term and even lifelong follow-up requirements, and consents to undergo the relevant infection surveillance and health management requirements for both the subject and, where necessary, close contacts. 7. Body mass index (BMI) 18–34 kg/m^2. 8.Completion of the pre-transplant infection prevention evaluation specified in this study; for recommended vaccines, vaccination has been completed or, as assessed by the study team, can be completed (including catch-up vaccination) within the specified time window without affecting study implementation. 9.For subjects of reproductive potential, they have received reproductive risk counseling and agree to use reliable contraception during the period specified in the study. Gamete cryopreservation may be recommended but is not a prerequisite for enrollment.
Exclusion criteria
Exclusion criteria: 1. Organ dysfunction: presence of severe multi-organ failure (e.g., heart, liver, or lung); 2. Active infection: active, uncontrolled bacterial, viral, fungal, or parasitic infection; 3. Uncontrolled malignant tumor; 4. Current pregnancy; 5. Hypercoagulable state; 6. Inability to receive blood transfusion; 7. Intolerance to immunosuppressive therapy; 8. Untreated psychiatric disorder; 9. Current illegal drug abuse and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recipient and graft survival time;Survival time of functional grafts;Incidence of acute humoral and cellular rejection, as well as incidence of chronic rejection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-Related Quality of Life in Participants Receiving the Xenokidney by the 36-Item Short Form Health Survey (SF-36);Incidence and duration of delayed graft function (DGF);Incidence of surgical site infections;Incidence of Proteinuria;Incidence of complement deposition, etc.;Incidence of renal allograft tumors (tumorigenicity);Complete blood count, liver and kidney function tests, biochemical assays, infectious diseases testing, and immunological markers.;Occurrence of opportunistic infections (such as Pneumocystis jirovecii pneumonia (PCP), cytomegalovirus (CMV), polyomavirus (BK), etc.);Prevalence of thrombocytopenia or indicators of consumptive coagulopathy after transplant with porcine kidney;The relief or exacerbation of hypertension (HTN). Blood pressure control status is reflected in the type and dosage of antihypertensive medications.;Incidence of hypotension or other blood pressure alterations, as renin produced by the pig kidney may not be able to cleave human angiotensinogen, evidenced by type and dosage of anti-hypertensive or;The possibility of promoting tumor formation;Incidence of myocardial infarction and/or stroke following xenotransplantation;Incidence of hospital acquired infection (i.e. pneumonia, urinary tract infection (UTI), Central Line-Associated Blood Stream Infection (CLABSI));Rate of new onset diabetes after transplant (NODAT) or worsening/improvement of control of pre-existing diabetes mellitus (DM) as evidenced by medications needed for glycemic control;Incidence of primary non-function (PNF); | — |
Countries
China
Contacts
Public ContactWang Yi
The Second Affiliated Hospital of Hainan Medical University
Outcome results
None listed