A randomized trial of three renal transplant induction antibodies: early comparison of tacrolimus, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring
Ciancio, G.; Burke, G.W.; Gaynor, J.J.; Carreno, M.R.; Cirocco, R.E.; Mathew, J.M.; Mattiazzi, A.; Cordovilla, T.; Roth, D.; Kupin, W.; Rosen, A.; Esquenazi, V.; Tzakis, A.G.; Miller, J.
Transplantation 80(4): 457-465
2005
ISSN/ISBN: 0041-1337 PMID: 16123718 Document Number: 592897
Background. New trends in immunosuppression in clinical transplantation include the use of antibody induction agents in protocols that emphasize reduction or avoidance of steroids and calcineurin inhibitors.Methods. In a randomized trial using three different antibody induction agents in 90 first renal transplant recipients from cadaver donors, group A received Thymoglobulin, group B received Alemtuzumab, and group C received Daclizumab. Maintenance immunosuppression included tacrolimus and mycophenolate in all three arms, and methylprednisolone in groups A and C only (standard clinical institutional practice). The targeted trough level of tacrolimus was between 8 and 10 ng/mL for groups A and C, respectively, with a targeted mycophenolate dose of I g twice daily. However, in group B, the target tacrolimus trough level was 4 to 7 ng/mL to reduce long-term nephrotoxicity, with 500 mg twice-daily doses of mycophenolate, without steroid maintenance.Results. In this 15-month median postoperative interval report, there were no notable differences in demographics and patient and graft survivals. Acute rejection rates at I year were equivalent, that is, 5 of 30 in all three groups (16.6%). In group B, there was slightly lower renal function at 1 month, but no difference at I year. There was also significantly more leukopenia, but a greater percentage of T-regulatory cells and number of Fox-P3 mRNA copies by flow cytometry and semiquantitative polymerase chain reaction analysis, respectively, in group B.Conclusions. This preliminary analysis indicates that 80% of the patients in group B remained steroid-free I year postoperatively, with lower tacrolimus trough levels and no difference in other adverse events.