Table 2.
Table 2: Summary of various parameters in different early conversion clinical trials | |||||
Authors | Study design | Time of conversion | Group 1 | Group 2 | |
A) Everolimus | |||||
Budde, et al, 2011, (ZEUS Study) [23] |
Multicenter randomized trial (n=300), 12 months, 36 months, 5 years | 4.5th month | EVR (C0, 6–10 ng/mL) Induction: Basiliximab (n=155) |
CsA ( C0, 120–180 ng/mL till 4.5–6 months then decreased to 100–150 ng/mL) Induction: Basiliximab (n=145) |
|
Mjornstedt, et al, 2012, (CENTRAL trial) [24] | Multicenter randomized trial (n=269), 5 years | 7th week | EVR (C0, 6–10 ng/mL) + MMF (1.4 g/d till 2 weeks then decreased to 1.08 g/d) + S (n=92) |
Low CsA ( C0, 75–200 ng/mL till 2 weeks then decreased to 50–150 ng/mL) + MMF (1.4 g/d) + S (n=90) |
|
B) Sirolimus | |||||
Lebranchu, et al, 2009, (CONCEPT Study) [25] |
Multicenter randomized trial (n=193), 12 months, 48 months | 3rd month | SRL (C0, 8–15 ng/mL till 39 weeks then decreased to 5–10 ng/ mL) + MMF + S Induction: Daclizumab (n=95) |
CsA (C0, 500–800 ng/mL) + MMF + S Induction: Daclizumab (n=97) |
|
Guba, et al, 2010, (SMART Trial) [26] | Multicenter randomized trial (n=140), 12 and 36 months | 10–24th day | SRL (C0, 8–12 ng/mL then decreased to 5–10 ng/ mL) + MMF (1.5 g/d) + S Induction: ATG (n=69) |
CsA (C0, 150–200 ng/mL then decreased to 100–150 ng/ mL) + MMF (2 g/d) + S Induction: ATG (n=71) |
|
Weir, et al, 2010, (Spare the Nephron Trial) [27] | Multicenter randomized trial (n=299), 2 years | Within 115 days | MMF + SRL (n=148) |
MMF + CNI (n=151) |
|
Heilman, et al, 2011 [28] | Multicenter randomized trial (n=122), 24 months | 1 month | SRL (C0, 9.8±3.6 ng/mL) + MMF + S Induction: Basiliximab (n=62) |
TAC (C0, 6.9±4.6 ng/mL) + MMF + S Induction: Basiliximab (n=60) |