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

Abstract

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. 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. 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). 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.