[Clinical study of single-dose of recombinant humanized anti-CD3 monoclonal antibody injection in kidney transplant recipients].

Objective: To evaluate short-term and long-term safety of using single-dose escalation of recombinant humanized anti-CD3 monoclonal antibody (OKT3) in kidney transplantation recipients.
Methods: A total of 29 recipients of cadaveric kidney transplant from June 2008 to December 2008 were sequently assigned to receive single-dose intravenous injection of OKT3 with different doses of 2.5 mg (n = 9), 5.0 mg (n = 10) and 10.0 mg (n = 10) at Days 7 - 14 post-operation. Meanwhile, a control group was established by selecting kidney transplant recipients, who did not participate in the trial in the same period. All patients were followed up for at least 2 years. During this period, liver function, kidney function, hemoglobin and other biochemical indicators were monitored and adverse events recorded over time.
Results: No obvious first dose effect was observed, except low heat (7/29), chills (4/29), mild liver damage (2/29), upper respiratory tract infection and headache (1/29) across all doses. Other adverse reactions were mild, unrelated with doses. The 2-year patients/grafts survival rates of treatment group and control group were 100%/100%, and 100%/97%, respectively. The incidence of acute rejection confirmed by renal biopsy was 6.9% (2/29) and 10.0% (3/30) in treatment group and control group, respectively. The incidence of lung infection was 10.3% (3/29) and 13.3% (4/30), respectively. The values of serum creatinine at 1 week and 3, 6, 12, 24 months showed no statistically significance in two groups (all P > 0.05).
Conclusion: It is safe to use single-shot OKT3 intravenously in kidney transplant recipients. The recombinant humanized OKT3 may be an effective immunosuppressive agent with milder toxicity for solid organ transplantation.