Randomized trial of rATg/Daclizumab vs. rATg/Alemtuzumab as dual induction therapy in renal transplantation: Results at 8 years of follow-up

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• 作者：Gaetano Ciancio^a ; ^{gciancio@med.miami.edu} ; Jeffrey J. Gaynor^a ; ^{jgaynor@med.miami.edu} ; Giselle Guerra^b ; ^{gguerra@med.miami.edu} ; Junichiro Sageshima^a ; ^{jsageshima@ucdavis.edu} ; David Roth^b ; ^{droth@med.miami.edu} ; Linda Chen^a ; ^{ljchen@med.miami.edu} ; Warren Kupin^b ; ^{wkupin@med.miami.edu} ; Adela Mattiazzi^b ; ^{amattiazzi@med.miami.edu} ; Lissett Tueros^a ; ^{ltueros@med.miami.edu} ; Sandra Flores^a ; ^{sflores@med.miami.edu} ; Lois Hanson^a ; ^{h_lois@bellsouth.net} ; Phillip Ruiz^a ; Rodrigo Vianna^a ; ^{r.vianna@med.miami.edu} ; George W. Burke III^a ; ^{gburke@med.miami.edu}
• 关键词：Renal transplantation ; Rabbit antithymocyte globulin ; Daclizumab ; Alemtuzumab ; Tacrolimus ; Enteric-coated mycophenolate sodium ; Steroid avoidance ; Biopsy-proven acute rejection ; Graft survival
• 刊名：Transplant Immunology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：40
• 期：Complete
• 页码：42-50
• 全文大小：639 K
• 卷排序：40

文摘

Our goal in using dual induction therapy is to bring the kidney transplant recipient closer (through more effectively timed lymphodepletion) to an optimally immunosuppressed state. Here, we report long-term results of a prospective randomized trial comparing (Group I,N = 100) rATG/Dac (3 rATG, 2 Dac doses) vs. (Group II,N = 100) rATG/Alemtuzumab(C1H) (1 dose each), using reduced tacrolimus dosing, EC-MPS, and early corticosteroid withdrawal. Lower EC-MPS dosing was targeted in Group II to avoid severe leukopenia. Median follow-up was 96 mo post-transplant. There were no differences in 1st BPAR (including borderline) rates: 10/100 vs. 9/100 in Groups I and II during the first 12mo(P = 0.54), and 20/100 vs. 20/100 throughout the study(P = 0.90). Equally favorable renal function was maintained in both treatment arms(N.S.). While not significant, more patients in Group II experienced graft loss, 25/100 vs. 18/100 in Group I(P = 0.23). Actuarial patient/graft survival at 96 mo was 92%/83% vs. 85%/73% in Groups I and II(N.S.). DWFG-due-to-infection(N.S.), EC-MPS withholding-due-to-leukopenia during the first 2mo(P = 0.03), and incidence of viral infections(P = 0.09) were higher in Group II, whereas EC-MPS withholding-due-to-GI symptoms was higher in Group I(P = 0.009). No other adverse event differences were observed. While long-term anti-rejection and renal function efficacy were demonstrated in both treatment arms, slight over-immunosuppression of Group II patients occurred.