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Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial Lionel Rostaing, MD, PhD, Suphamai Bunnapradist, MD, Josep M. Grinyó, MD, Kazimierz Ciechanowski, MD, PhD, Jason E. Denny, MD, Helio Tedesco Silva, MD, Klemens Budde, MD Jason E. Denny, MD, Sanjay Kulkarni, MD, Donald Hricik, MD, Barbara A. Bresnahan, Suphamai Bunnapradist, Rafik A. El-Sabrout, Laurence K. Chan, Gaetano Ciancio, Mohamed A. El-Ghoroury, Michael J. Goldstein, Robert S. Gaston, Reginald Y. Gohh, Mary T. Killackey, Anne King, Richard J. Knight, Arputharaj H. Kore, Debra L. Sudan, Javier Chapochnick Friedmann, Shamkant P. Mulgaonkar, Charles Nolan, Oleh G. Pankewycz, John D. Pirsch, Heidi M. Schaefer, Steven M. Steinberg, Bruce E. Gelb, Karin A. True, Patricia M. West-Thielke, Mary M. Waybill, Joshua H. Wolf, Beverley L. Ketel, Robert C. Harland, Fuad S. Shihab, Elisabeth Cassuto, Yannick Le Meur, Lionel Rostaing, Christophe Mariat, Josep Maria Grinyó, Jose Puig, Daniel Seron, Giuseppe Tisone, Kazimierz Ciechanowski, Bartosz Foroncewicz, Zbigniew Wlodarczyk, Klemens Budde, Oliver Witzke, Guillermo A. Mondragon, Eduardo Mancilla Urrea, Josefina Alberu Gomez, Rafael Reyes Acevedo, Maria del Carmen Rial, Pablo A. Novoa, Helio T. Silva, Valter D. Garcia, Deise D. Carvalho, Luciana T. Santamaria Saber, Fabiana L. Contieri, Marcos G. Bastos, Roberto C. Manfro, John Kanellis, Josette Eris, Philip O’Connell, Peter Hughes, Graeme Russ, Grant B. Pidgeon, Ian D. Dittmer, Terence Kee, Anantharaman Vathsala, Radomir Naumovic, Igor Mitic, Randhawa Parmjeet, MD Lionel Rostaing, MD, PhD, Suphamai Bunnapradist, MD, Josep M. Grinyó, MD, Kazimierz Ciechanowski, MD, PhD, Jason E. Denny, MD, Helio Tedesco Silva, MD, Klemens Budde, MD Jason E. Denny, MD, Sanjay Kulkarni, MD, Donald Hricik, MD, Barbara A. Bresnahan, Suphamai Bunnapradist, Rafik A. El- Sabrout, Laurence K. Chan, Gaetano Ciancio, Mohamed A. El-Ghoroury, Michael J. Goldstein, Robert S. Gaston, Reginald Y. Gohh, Mary T. Killackey, Anne King, Richard J. Knight, Arputharaj H. Kore, Debra L. Sudan, Javier Chapochnick Friedmann, Shamkant P. Mulgaonkar, Charles Nolan, Oleh G. Pankewycz, John D. Pirsch, Heidi M. Schaefer, Steven M. Steinberg, Bruce E. Gelb, Karin A. True, Patricia M. West-Thielke, Mary M. Waybill, Joshua H. Wolf, Beverley L. Ketel, Robert C. Harland, Fuad S. Shihab, Elisabeth Cassuto, Yannick Le Meur, Lionel Rostaing, Christophe Mariat, Josep Maria Grinyó, Jose Puig, Daniel Seron, Giuseppe Tisone, Kazimierz Ciechanowski, Bartosz Foroncewicz, Zbigniew Wlodarczyk, Klemens Budde, Oliver Witzke, Guillermo A. Mondragon, Eduardo Mancilla Urrea, Josefina Alberu Gomez, Rafael Reyes Acevedo, Maria del Carmen Rial, Pablo A. Novoa, Helio T. Silva, Valter D. Garcia, Deise D. Carvalho, Luciana T. Santamaria Saber, Fabiana L. Contieri, Marcos G. Bastos, Roberto C. Manfro, John Kanellis, Josette Eris, Philip O’Connell, Peter Hughes, Graeme Russ, Grant B. Pidgeon, Ian D. Dittmer, Terence Kee, Anantharaman Vathsala, Radomir Naumovic, Igor Mitic, Randhawa Parmjeet, MD American Journal of Kidney Diseases Volume 67, Issue 4, Pages (April 2016) DOI: /j.ajkd Copyright © 2016 The Authors Terms and Conditions
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Figure 1 Patient disposition. Abbreviations: AE, adverse event; LCPT, extended-release tacrolimus, once daily. American Journal of Kidney Diseases , DOI: ( /j.ajkd ) Copyright © 2016 The Authors Terms and Conditions
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Figure 2 Mean (± standard error) tacrolimus trough levels and tacrolimus daily dose over the 24-month study period. Abbreviations: LCPT, extended-release tacrolimus, once daily; TDD, total daily dose. American Journal of Kidney Diseases , DOI: ( /j.ajkd ) Copyright © 2016 The Authors Terms and Conditions
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Figure 3 Mean (± standard error) tacrolimus trough level (ng/mL) achieved per total daily dose (TDD; mg). Abbreviation: LCPT, extended-release tacrolimus, once daily. American Journal of Kidney Diseases , DOI: ( /j.ajkd ) Copyright © 2016 The Authors Terms and Conditions
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Figure 4 Kaplan-Meier analysis, proportion free of treatment failure over 24 months. Abbreviation: LCPT, extended-release tacrolimus, once daily. American Journal of Kidney Diseases , DOI: ( /j.ajkd ) Copyright © 2016 The Authors Terms and Conditions
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Figure 5 Forest plot of difference (95% confidence interval) in treatment failure for extended-release tacrolimus, once daily (LCPT) versus twice-daily tacrolimus by patient subgroups and overall. American Journal of Kidney Diseases , DOI: ( /j.ajkd ) Copyright © 2016 The Authors Terms and Conditions
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