[Evaluation of long-term effect of adding low-dose daclizumab to standard protocol on kidney rejection in kidney recipients]

ABSTRACT

Daclizumab is a monoclonal antibody directed against CD25 subunit of interlukin 2 receptor. Several studies have shown the effectiveness of daclizumab on reduction of acute rejection in renal transplantation with regular or limited dose. The present study assessed the outcomes of 3 and 5 years follow-up of a prospective case-control trial comparing safety and efficacy of induction therapy with two doses of daclizumab, compared with no induction treatment, in renal transplant recipients. This clinical-trial study was started in 2006 on 140 living donor kidney recipients admitted to kidney transplant ward of Kerman Afzalipour hospital, Iran. These patients were randomly assigned into two 70 patients, intervention and control groups. All patients received cyclosporine, mycophenolate mofetil and prednisolone. Intervention group recieved daclizumab at a dose of 1 mg/kg before transplantation and then two weeks later, also. All patients were followed up for 3 and 5 years for graft and patient survival and side effect of daclizumab, so.After 3 years, 58 patients remained in case and 61 in control group. Function of transplanted kidney was evaluated on base of calculated glomerular filtration rate [GFR], and after 3 and 5 years, were same between two groups. Rate of sepsis was same between two groups but infection with varicella zuster, in first 6 months after transplantation, was significantly more in intervention group [P = 0.04].Daclizumab did not have any effect on patient or graft survival. It did not increase the rate of sepsis but might increase the rate of varicella zuster infection