PURPOSE: The safety and efficacy of reduced-dose cyclosporine in renal transplantation were studied. METHODS:Patients receiving their first renal transplant receiveddaclizumab 1 mg/kg every 14 days for a total of five doses, mycophenolate mofetil 1 g twice daily, corticosteroids per the institution's routine protocol, and half of the institution's usual cyclosporine dosage. Trough cyclosporine concentrations targeted were half the customary goals, or 150-200 ng/mL for the first six months and 125-175 ng/mL for months 7-12. A retrospective control group included 15 matched patients who had received full-dosecyclosporine, mycophenolate mofetil, and corticosteroids without daclizumab induction therapy. RESULTS:Thirty patients were studied (15 in each group). At baseline, the control group had a significantly lower panel reactive antibody level (0.13%) than the treatment group (5.2%) (p = 0.01). Mean cyclosporine concentrations at 1, 6, and 12 months were significantly lower in the treatment group (p < 0.0001). No patient in either group had an acute rejection episode. All control patients had cyclosporine-associated adverse effects, compared with seven treatment-group patients (p = 0.0022). The treatment group had 19 infections, versus 29 in the control group (p = 0.39). Three study-group patients and eight control patients required a fine-needle aspiration or biopsy (p = 0.13). CONCLUSION: Among kidney transplant patients at low risk of acute rejection, those treated with daclizumab and low-dose cyclosporine had an identical rate of acute rejection (none) and fewer cyclosporine-associated adverse effects compared with patients in a retrospective control group who received full-dose cyclosporine without daclizumab.
RCT Entities:
PURPOSE: The safety and efficacy of reduced-dose cyclosporine in renal transplantation were studied. METHODS:Patients receiving their first renal transplant received daclizumab 1 mg/kg every 14 days for a total of five doses, mycophenolate mofetil 1 g twice daily, corticosteroids per the institution's routine protocol, and half of the institution's usual cyclosporine dosage. Trough cyclosporine concentrations targeted were half the customary goals, or 150-200 ng/mL for the first six months and 125-175 ng/mL for months 7-12. A retrospective control group included 15 matched patients who had received full-dose cyclosporine, mycophenolate mofetil, and corticosteroids without daclizumab induction therapy. RESULTS: Thirty patients were studied (15 in each group). At baseline, the control group had a significantly lower panel reactive antibody level (0.13%) than the treatment group (5.2%) (p = 0.01). Mean cyclosporine concentrations at 1, 6, and 12 months were significantly lower in the treatment group (p < 0.0001). No patient in either group had an acute rejection episode. All control patients had cyclosporine-associated adverse effects, compared with seven treatment-group patients (p = 0.0022). The treatment group had 19 infections, versus 29 in the control group (p = 0.39). Three study-group patients and eight control patients required a fine-needle aspiration or biopsy (p = 0.13). CONCLUSION: Among kidney transplant patients at low risk of acute rejection, those treated with daclizumab and low-dose cyclosporine had an identical rate of acute rejection (none) and fewer cyclosporine-associated adverse effects compared with patients in a retrospective control group who received full-dose cyclosporine without daclizumab.
Authors: Peter Attia; Ajay V Maker; Leah R Haworth; Linda Rogers-Freezer; Steven A Rosenberg Journal: J Immunother Date: 2005 Nov-Dec Impact factor: 4.456