Received an allogeneic kidney transplant
Conditions
Interventions
Test group:Group anti-CD25 humanized monoclonal antibody was given intravenously 24 h before surgery (the first time) and 8 days after surgery (the second time). Recombinant humanized monoclonal antib
Sponsors
Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must also meet all of the following criteria: 1) The subjects are male or female aged 18-65 years; 2) Subjects receiving allograft kidney transplantation for the first time; 3) No other serious diseases; 4) The subjects voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are excluded: 1) Recipients of combined transplantation at the same time; 2) There are active infected persons; 3) Patients with acute hepatitis or abnormal liver function > 2 times the upper limit of normal value (ULN); 4) Group response antibody level (PRA) > 10%; 5) Patients with a history of malignant tumors (within the past 5 years); 6) White blood cell count < 3×109/L or hemoglobin < 50 g/L; 7) Any type of mental illness. 8) Patients with severe diarrhea, severe gastrointestinal disease and active peptic ulcer disease; 9) Serious heart disease with abnormal heart function; 10) Patients participating in other research trials or receiving immunosuppressive therapy prohibited in this study. 11) Currently participating in clinical trials of other drugs or medical devices; 12) Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute rejection (AR) within 6 months after transplantation in subjects (pathological confirmation required).;Changes of serum IL-2R level; | — |
Secondary
| Measure | Time frame |
|---|---|
| infection rate;Changes in serum creatinine (SCr) concentration, time to return to normal after renal transplantation, and SCr concentration did not return to normal proportions at 3 and 6 months after transplantation.;The time when AR first occurred;Incidence of delayed graft function;Adverse event rate; | — |
Countries
China
Contacts
Public ContactTongyu Zhu
Zhongshan Hospital
Outcome results
None listed