29 December 2021: Meta-Analysis
Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials
T A Manjunatha 1ABCDEF* , Rebecca Chng 1ABCDEF , Wai-Ping Yau 2ADEDOI: 10.12659/AOT.933588
Ann Transplant 2021; 26:e933588
Table 1 Overview of included studies in which 1 or more of the treatment arms used Advagraf or Prograf.
| Study | TAC formulation | Phase | Blinding | Center | Region* | Sample size | Efficacy outcomes | Safety outcomes | No. of arms |
|---|---|---|---|---|---|---|---|---|---|
| Albano 2013 | Advagraf, Prograf | 4 | Open-label | Multicenter | International | 1251 | Y | Y | 4 |
| Anutrakulchai 2019 | Prograf | – | Open-label | Single-center | Asia | 126 | Y | N | 2 |
| Arns 2017 | TacHexal, Prograf | 4 | Open-label | Multicenter | Europe | 81 | Y | Y | 2 |
| Arriola 2018 (CA) | Advagraf, Prograf | – | – | – | – | 107 | Y | Y | 2 |
| Asher 2014 | Prograf | – | Open-label | Single-center | Europe | 62 | Y | N | 2 |
| Bakr 2018 | Advagraf, Prograf | – | – | Single-center | Africa | 99 | Y | N | 2 |
| Chen 2008 | Prograf | – | Single-blind | – | Asia | 41 | Y | Y | 2 |
| Cockfield 2019 | Advagraf | – | Open-label | Multicenter | North America | 281 | Y | Y | 2 |
| De Graav 2017 | Prograf | – | Open-label | Single-center | Europe | 40 | Y | N | 2 |
| Demirbas 2009 | Prograf | 4 | Open-label | Multicenter | International | 1645 | Y | Y | 4 |
| Ekberg 2010 (SP to Demirbas 2009) | Prograf | 4 | Open-label | Multicenter | International | 1645 | Y | Y | 4 |
| Ferguson 2011 | Prograf | 2 | Open-label | Multicenter | International | 89 | Y | Y | 3 |
| Frei 2010 (SP to Demirbas 2009) | Prograf | 4 | Open-label | Multicenter | International | 1645 | Y | N | 4 |
| Gaston 2009 | Prograf | 4 | Open-label | Multicenter | North America | 720 | Y | Y | 3 |
| Hamdy 2008 | Prograf | – | – | Single-center | Africa | 132 | Y | Y | 2 |
| Harland 2019 | Prograf | 2a | Open-label | Multicenter | North America | 149 | Y | Y | 3 |
| Huh 2017 | Advagraf | 4 | Open-label | Multicenter | East Asia | 158 | Y | N | 2 |
| Kramer 2010a | Prograf | 3 | Open-label | Multicenter | Europe | 451 | Y | Y | 3 |
| Kramer 2010b | Advagraf, Prograf | 3 | Mixed# | Multicenter | International | 676 | Y | Y | 2 |
| Kramer 2012 (SP to Kramer 2010a) | Prograf | 3 | Open-label | Multicenter | Europe | 451 | Y | Y | 3 |
| Langer 2012 | Prograf | 3 | Open-label | Multicenter | International | 228 | Y | Y | 2 |
| Liu 2015 | Prograf | – | Open-label | Single-center | Asia | 72 | Y | Y | 2 |
| Tedesco-Silva 2014 | Astagraf (Advagraf), Prograf | 3 | Open-label | Multicenter | International | 668 | Y | Y | 3 |
| Tsuchiya 2013 | Graceptor (Advagraf), Prograf | – | Open-label | Multicenter | Asia | 102 | Y | Y | 2 |
| * Region refers to the geographical region identified based on the study locations and could be any of either Africa, Asia, East Asia, Europe, North America, South America, or International if the study was carried out in multiple regions across the world. # Kramer 2010b used a mixed approach that comprised an initial double-blind, double-dummy phase followed by an open-label observation period post-transplant. CA – conference abstract; N – no; SP – secondary publication; TAC – tacrolimus; Y – yes. | |||||||||