Rejection
Conditions
Interventions
Experimental Group:1. The recipient of the participant received a single dose of Eculizumab one day before the transplantation surgery (900 mg for weight >=60kg). For those with a body weight of less
600 mg for weight < 60kg).
2. When the participants' receptors develop AMR, they may receive an additional dose of Eculizumab.
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, and completed genetic sequencing screening to exclude hereditary kidney diseases, as well as mutations in complement genes. 2. Suffering from end-stage renal disease, undergoing first-time kidney transplantation, with ethical approval for living donor kidney transplantation and planned for ABO-incompatible living donor kidney transplantation, and with a preoperative blood type antibody titer >= 1:64 in the recipient. 3. Vaccinated against Neisseria meningitidis (quadrivalent vaccine), Streptococcus pneumoniae, or Haemophilus influenzae at least 6 weeks prior to the use of eculizumab. 4. Able to understand the informed consent form and willing to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. History of previous splenectomy. 2. Presence of explicit contraindications to kidney transplantation, including but not limited to: active, uncontrollable infections, including bacterial, fungal, and viral infections. 3. Known or suspected hereditary complement deficiency, with genetic sequencing confirming mutations in complement-related genes. 4. Known allergy to the investigational drug or its excipients. 5. Patients who require preoperative combination of plasma exchange or immunoadsorption as pretreatment. 6. History of meningococcal disease. 7. Any health condition that the investigator considers may interfere with the patient's participation, pose additional risks to the patient, or confound the patient's evaluation (such as severe cardiovascular or pulmonary diseases). 8. Subjects currently participating in other clinical trials, or those deemed by the investigators as unsuitable for the clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C5a;C5b9;CH50;The concentration of Eculizumab;Titer of blood group antibodies;Creatinine;B lymphocyte count;Urea nitrogen; | — |
Secondary
| Measure | Time frame |
|---|---|
| White blood cell count;Platelet count ; | — |
Countries
China
Contacts
Public ContactQiquan Sun
Guangdong Provincial People's Hospital
Outcome results
None listed