Gender association and low dose of Daclizumab in comparison with standard regimen to prevent rejection in kidney transplant patients

Seyed Mojtaba Sohrevardi1, Jalal Azmandian2, Zahra Shafiee2. 1Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Clinical Pharmacy, Postcode:8915173143, Iran, 2Scholl of Medicine, Kerman University of Medical Sciences, Internal Medicine, Iran

Introduction: One of the most important therapeutic problems in kidney transplant patients is prevention of acute graft rejection. The purpose of this study was to investigate the efficacy of low dose Daclizumab (Zenapax®) for prevention of acute kidney graft rejection in living donor recipients. We evaluated 6 months survival analysis to find out if there is any diffrences between men and women in two groups. This research approved by ethic comitte and clinical trial registry number is IRCT138802021836N1.

Method and material: This clinical trial study were performed on 120 living donor kidney recipients who was admitted in kidney transplant ward of Kerman Afzalipor hospital, Iran. In the case group 60 patients involved the study after obtaining informed consent and low-dose Daclizumab (1 mg/kg in days 0 and 14 after surgery) was added to their standard treatment protocol which consisted of Cyclosporine (5-8 mg/Kg and then dose adjustment based on serum level), Prednisolone (1 mg/Kg and then slow decreasing) and Mycophenolate mofetil (Cellcept® 2gr/d). Another 60 patients were enrolled as the control group and received the standard treatment protocol only. Data were analyzed by using SPSS 15 software according to the study objectives. Proportion (%) of rejection in each group was separately calculated and compared with Chi-square test (X2). Logrank test was used for survival analyzing.

Results: The rate of acute rejection was significantly lower in case group (6.7% vs. 18.3%; P=0.048). Six months graft survival rates in case group was 95% (95% CI:92%-98%) and in control group was 85% (95%CI: 81%-89%). Comparing gender, women\'s 6 months survival rate was 97% (95% CI: 95%-99%) in the case group and 74 %( 95% CI:65%-83%) in the control group; the difference was statistically significant (P=0.02). However, the difference in 6 months survival rate among men in case group94% (95% CI: 90%-98%) was not statistically significant (P=0.75) with control group 92 %( 95%CI: 88%-96%).

Discussion: The use of induction therapy with two doses of Daclizumab in living donors kidney reciepients reduces the incidens of acute rejection with improving graft survival espacially in women and dosen’t result in more infectious complication.

Keywords: Daclizumab, Renal transplantation, Acute rejection, Gender