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

Gaetano Ciancio, Jeffrey J. Gaynor, Giselle Guerra, Junichiro Sageshima, David Roth, Linda Chen, Warren Kupin, Adela Mattiazzi, Lissett Tueros, Sandra Flores, Lois Hanson, Phillip Ruiz, Rodrigo Vianna, George W. Burke

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)42-50
Number of pages9
JournalTransplant Immunology
Volume40
DOIs
StatePublished - Feb 1 2017
Externally publishedYes

Fingerprint

Kidney Transplantation
Leukopenia
Kidney
Arm
Transplants
Tacrolimus
Graft Survival
Virus Diseases
Immunosuppression
Adrenal Cortex Hormones
Therapeutics
Incidence
Infection
daclizumab
alemtuzumab
Transplant Recipients

Keywords

  • Alemtuzumab
  • Biopsy-proven acute rejection
  • Daclizumab
  • Enteric-coated mycophenolate sodium
  • Graft survival
  • Rabbit antithymocyte globulin
  • Renal transplantation
  • Steroid avoidance
  • Tacrolimus

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Transplantation

Cite this

Randomized trial of rATg/Daclizumab vs. rATg/Alemtuzumab as dual induction therapy in renal transplantation : Results at 8 years of follow-up. / Ciancio, Gaetano; Gaynor, Jeffrey J.; Guerra, Giselle; Sageshima, Junichiro; Roth, David; Chen, Linda; Kupin, Warren; Mattiazzi, Adela; Tueros, Lissett; Flores, Sandra; Hanson, Lois; Ruiz, Phillip; Vianna, Rodrigo; Burke, George W.

In: Transplant Immunology, Vol. 40, 01.02.2017, p. 42-50.

Research output: Contribution to journalArticle

Ciancio, G, Gaynor, JJ, Guerra, G, Sageshima, J, Roth, D, Chen, L, Kupin, W, Mattiazzi, A, Tueros, L, Flores, S, Hanson, L, Ruiz, P, Vianna, R & Burke, GW 2017, 'Randomized trial of rATg/Daclizumab vs. rATg/Alemtuzumab as dual induction therapy in renal transplantation: Results at 8 years of follow-up', Transplant Immunology, vol. 40, pp. 42-50. https://doi.org/10.1016/j.trim.2016.11.004
Ciancio, Gaetano ; Gaynor, Jeffrey J. ; Guerra, Giselle ; Sageshima, Junichiro ; Roth, David ; Chen, Linda ; Kupin, Warren ; Mattiazzi, Adela ; Tueros, Lissett ; Flores, Sandra ; Hanson, Lois ; Ruiz, Phillip ; Vianna, Rodrigo ; Burke, George W. / Randomized trial of rATg/Daclizumab vs. rATg/Alemtuzumab as dual induction therapy in renal transplantation : Results at 8 years of follow-up. In: Transplant Immunology. 2017 ; Vol. 40. pp. 42-50.
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abstract = "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.",
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