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A randomized trial of three renal transplant induction antibodies: early comparison of tacrolimus, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring.

Author(s): Ciancio G, Burke GW, Gaynor JJ, Carreno MR, Cirocco RE, Mathew JM, Mattiazzi A, Cordovilla T, Roth D, Kupin W, Rosen A, Esquenazi V, Tzakis AG, Miller J

Affiliation(s): Dept. of Surgery, The Lillian Jean Kaplan Renal Transplant Center of the Division of Transplantation, University of Miami Leonard M. Miller School of Medicine, and the Miami Veterans Affairs Medical Center, Miami, Florida 33101, USA. gciancio@med.miami.edu

Publication date & source: 2005-08-27, Transplantation., 80(4):457-65.

Publication type: Clinical Trial; Randomized Controlled Trial

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 1 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 1 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 1 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 1 year postoperatively, with lower tacrolimus trough levels and no difference in other adverse events.

Page last updated: 2006-01-31

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