Table 1.
Study (year) | Treatment | N (female %) | White % | First Transplant % | Deceased Donor % | Cold Ischemia time (SD) | Mean Donor Age (SD) | Mean Age (SD) | Study design, location, time of follow-up and funding |
---|---|---|---|---|---|---|---|---|---|
1. CNI vs. CNI | |||||||||
1.Scantleburry (1991) [22] | CsA + Pred TAC + Pred |
20 14 |
NR NR |
100 100 |
NR NR |
NR NR |
NR NR |
NR NR |
RCT, USA, single center, 12 months |
2. Mayer (1997) [23] | CsA + AZA + Pred TAC + AZA + Pred |
145 (36.6) 303 (35.3) |
NR NR |
89.7 90.4 |
100 100 |
NR NR |
43.0 45.2 |
45.8 46.6 |
RCT, England, multicenter (15), open label, 12 months, funded by Fujisawa GMBH |
3. Yang (1999) [24] | CsA + MMF + Ster TAC + MMF + Ster |
30 (37) 30 (50) |
87.0 77.0 |
NR NR |
57.0 67.0 |
15 (1.6) 14 (1.5) |
37 (2.6) 39 (3.0) |
48.0 (2.2) 45.0 (2.4) |
RCT, USA, single center, open label, 12 months |
4. Wang (2000) [25] | CsA + MMF + Pred TAC + MMF + Pred |
32 25 |
NR NR |
NR NR |
100 100 |
NR NR |
NR NR |
38.1 (18.7) | RCT, China, single center, 12 months results |
5. Nichelle (2002) [26] | CsA + AZA + Ster TAC + AZA + Ster |
46 48 |
NR NR |
NR NR |
NR NR |
NR NR |
NR NR |
NR NR |
RCT, France, single center, 12 and 36 months |
6. Campos (2002) [27] | CsA TAC |
81 (44) 85 (52) |
NR NR |
94 96 |
52.0 46.0 |
NR NR |
37.5(14.3) 36.5(13.7) |
40.9 (12.3) 40.5 (10.7) |
RCT, Brazil, multicenter (15), open label, 12 months |
7. Murphy (2003) [28] | CsA + Pred + AZA TAC + Pred + AZA |
50 (30.0) 52 (38.5) |
NR NR |
88.0 88.0 |
84.0 82.0 |
LD:1.7; CAD:19.0; NHBD:15.5; LD: 2.2; CAD:18.7; NHBD:15.1 |
LD:49; CAD:44; NHBD:48; LD:45; CAD:39; NHBD:49 |
45.0 (12.0) 45.0 (14.0) |
RCT, England, multicenter (2), open label, 12 months |
8. Jurewicz (2003) [66] | CsA + AZA + Ster TAC + AZA + Ster |
117 115 |
NR NR |
NR NR |
NR NR |
NR NR |
NR NR |
NR NR |
Cohort, United Kingdom, single center, 72months |
9. Hardinger (2005) [29] | CsA + AZA + Ster TAC + AZA + Ster |
66 (39) 134 (36) |
79 79 |
100 100 |
51.0 58.0 |
12 (4) 13 (5) |
NR NR |
44,0 (13.0) 46,0 (13.0) |
RCT, USA, single center, open label, 12 months |
10. Fukuhara (2005) [67] | CsA + Pred TAC + Pred |
137 (36.5) 55 (30.9) |
NR NR |
NR NR |
100 100 |
11.95 (6.12) 12.13 (6.58) |
47 (18) 46 (16) |
44 (9) 42 (11) |
Cohort, Japan, single Center, 10 years |
11. Silva (2006) [68] | CsA + AZA/MMF TAC + AZA/MMF |
80 (44) 68 (50) |
50 53 |
91 85 |
100 100 |
21 (8) 18 (7) |
34 (14.0) 34 (12.0) |
42 (12.0) 43 (12.0) |
Cohort, Brazil, single center, 12 months |
12. Silva, Jr. (2007) [30] | CsA + Pred TAC + Pred TAC XL + Pred |
212 (35.5) 212 (35.8) 214 (38.7) |
76.9 71.7 74.8 |
95.8 96.3 96.3 |
47.6 50.0 51.9 |
18.44 (7.11) 19.41 (7.27) 17.88 (7.73) |
NR NR NR |
47.6 (13.0) 48.6 (12.9) 47.8 (13.0) |
RCT, Brazil, , multicenter (60), open label, 12 months, funded by AstellasPharma US |
13. Cheung (2009) [31] | CsA + Pred TAC + Pred |
38 (34.2) 38 (44.8) |
100a 100a |
100 100 |
100 100 |
8.7 (4.6) 9.1 (5.1) |
48.9 (13.2) 48.9 (13.2) |
40.2 (11.7) 41.8 (7.5) |
RCT, China, single center, open label, 60 months |
14. Vicenti (1996) [32] | CsA TAC |
28 (21.4) 92 (34.8) |
53.6 51.1 |
100 100 |
NR NR |
NR NR |
NR NR |
46.6 44.1 |
RCT, USA, multicenter (5), open label, 12 months |
2. CNI vs. CNI + AMETAB | |||||||||
1. Moreso (1998) [33] | CsA + Pred CsA + MMF(ld) + Pred CsA + MMF + Pred CsA(ld) + MMF + Pred |
27 (48.2) 27 (44.4) 28 (42.9) 15 (33.3) |
NR NR NR NR |
37.0 44.4 46.4 93.4 |
100 100 100 100 |
NR NR NR NR |
41 (16) 41 (18) 42 (17) 44 (14) |
47 (15) 45 (14) 43 (15) 47 (7) |
RCT, Spain, multicenter (2), double blind in the standard dose CsA groups and open label in the low-dose CsA, 24 months |
2. Raofi (1999) [34] | CsA + AZA TAC + Pred |
21 (27.7) 14 (22.9) |
100b 100b |
100 100 |
100 100 |
26 (10) 25 (8) |
NR NR |
46.0 (11.0) 44.0 (14.0) |
RCT, USA, single center, 12 months |
3. Sandrini (2000) [35] | CsA + Pred CsA + AZA + Pred |
58 (45.0) 58 (38.0) |
NR NR |
100 100 |
100 100 |
NR NR |
35 (14) 35 (16) |
42 (11) 44 (10) |
RCT, Italy, single center, 60 months |
4. Segoloni (2000) [36] [Pascual (2003)] [37] | TAC + Pred TAC + AZA + Pred |
236 (35.2) 239 (35.6) |
NR NR |
NR NR |
100 100 |
18.0 17.6 |
NR NR |
46.0 45.0 |
RCT, Italy and Spain, multicenter (36), open label, 12 and 36 months |
5. Chang (2001) [38] | TAC + Ster TAC + AZA + Ster |
124 (37.9) 121 (32.2) |
77,4 76,0 |
NR NR |
NR NR |
20.4 21.3 |
NR NR |
48.0 45.0 |
RCT, United Kingdom, multicenter (08), open label, 12 months |
6. Squiflet (2001) [39] | TAC + Pred TAC + MMF(ld) + Pred TAC + MMF + Pred |
82 (46.3) 79 (32.9) 71 (36.6) |
93.9 97.5 95.8 |
86.6 87.3 90.1 |
100 100 100 |
NR NR NR |
45.6 (18.1) 45.6 (16.0) 45.4 (16.9) |
46.6 (14.5) 46.5 (13.3) 48.0 (13.3) |
RCT, Belgium, multicenter (16), 12 months, funded by Fujisawa |
3. CNI vs. AMETAB | |||||||||
1. Hall (1988) [40] | CsA AZA + Pred |
138 (42.8) 138 (45.0) |
NR NR |
100 100 |
100 100 |
22.0 22.7 |
NR NR |
NR NR |
RCT, Australia, multicenter (7), 36 months, funded by Sandoz |
2. Schnuelle (2001) [41] | CsA + Ster MMF + Ster |
44 (27.3) 40 (45.0) |
NR NR |
95,5 97,5 |
NR NR |
21.7 (9.0) 21.0 (7.5) |
40.7 (15.3) 47.7 (15.4) |
44.7 (13.3) 51.3 (11.5) |
RCT, Germany, multicenter (3), open label,12 months |
3. Hamdy (2008) [42] | TAC + SRL + Pred MMF + SRL + Pred |
65 (20.0) 67 (29.8) |
NR NR |
100 100 |
0 0 |
NR NR |
35.6 (10.3) 36.2 (10.2) |
32.3 (10.3) 31.8 (8.6) |
RCT, Egypt, single center, 63 months |
4. CNI vs. TOR-I | |||||||||
1. Groth (1998) [43] | CsA + AZA + Pred SRL + AZA + Pred |
42 (40.0) 41 (29.0) |
88.0 98.0 |
100 100 |
100 100 |
17.4 (7.2) 18.9 (7.4) |
37.7 (15.9) 44.6 (13.4) |
41.6 (11.8) 47.5 (10.8) |
RCT, Sweden, multicenter (11), open label, 12 months |
2. Büchler (2007)[44]Lebranchu (2012) [45] | CsA + MMF + Ster SRL + MMF + Ster |
74 (39.2) 71 (38.0) |
95.9 94.4 |
89.2 95.8 |
100 100 |
20.17 (5.46) 19.30 (5.24) |
41.3 (14.0) 38.7 (14.4) |
45.1 (12.4) 45.6 (10.3) |
RCT, France, multicenter (13), 12 months, funded by Wyeth |
3. Guba (2010) [46] | CsA + MMF + Ster SRL + MMF + Ster |
71 70 |
98.6 98.6 |
89.9 94.4 |
88.4 90.1 |
13.0 (7.0) 12.1 (5.7) |
47.1 (14.3) 46.9 (14.3) |
47.1 (11.1) 47.0 (10.8) |
RCT, Germany, multicenter (9), 12 months, funded by Wyeth and Fresenius Biotech |
4.Glotz (2010) [47] | TAC + MMF + Ster SRL + MMF + Ster |
70 71 |
91.4 77.5 |
94.3 94.4 |
100 100 |
18 (6) 19 (5) |
45.1 (12.6) 45.2 (13.4) |
46.7 (10.6) 48.5 (9.5) |
RCT, France, multicenter (13), 12 months, funded by Wyeth |
5. CNI + AMETAB vs. CNI + AMETAB vs. CNI + AMETAB | |||||||||
1. Hernandez (2007) [48] | CsA + AZA + Ster CsA + MMF + Ster TAC + MMF + Ster |
80 (26.2) 80 (37.5) 80 (45.0) |
NR NR NR |
100 100 100 |
42 50 59 |
20.3 (4) 21.0 (4) 21 (4) |
45 (16) 42 (15) 44 (17) |
47 (12) 48 (14) 47 (11) |
RCT, Spain, single center, open label, 24 months, funded by Spanish Health Ministry |
6. AMETAB vs. AMETAB | |||||||||
1. Keown (1995) [49] | AZA + CsA + Pred MMF + CsA + Pred MMF(hd) + CsA + Pred |
173 (46.2) 166 (33.1) 164 (40.2) |
NR NR NR |
10.4 14.46 10.98 |
NR NR NR |
20 (7) 21 (9) 20 (7) |
38 (16) 39 (16) 37 (16) |
46 (13) 47 (13) 46 (13) |
RCT, Canada, multicenter (21), double blind, 24 months |
2. Pescovitz (1998) [50] [Pescovitz (2001)] [51] |
AZA + CsA + Ster MMF + CsA + Ster |
108 (40.7) 113 (36.3) |
68.5 21.3 |
87 91 |
NR NR |
NR NR |
NR NR |
43.7 (11.7) 43.1 (11.6) |
RCT, USA, multi centric (15), double blind, 12 and 36 months |
3. Folkmane (2002) [52] | AZA + CsA + Pred MMF + CsA + Pred |
23 23 |
NR NR |
NR NR |
100 100 |
NR NR |
NR NR |
43.2 (12.1) 43.2 (12.1) |
RCT, Lithonia, 12 months |
4. Sadek (2002) [53] | AZA + CsA + Pred MMF + CsA + Pred |
157 (29.0) 162 (40.1) |
91.4 90.4 |
100 100 |
87 86 |
NR NR |
NR NR |
43.9 (12.8) 43.9 (13.0) |
RCT, United Kingdom, multicenter (28), open label, 12 months, funded by Novartis |
7. AMETAB vs. TOR-I | |||||||||
1. Vitko (2004) [54] [Vitko (2005)] [55] |
MMF + CsA EVR(hd) + CsA EVR(ld) + CsA |
194 198 196 |
NR NR NR |
100 100 100 |
NR NR NR |
NR NR NR |
RCT, Czech Republic, multicenter (54), double blind, 12 and 36 months, funded by Novartis | ||
2. Lorber (2005) [56] | MMF + CsA + Pred EVR(hd) + Csa + Pred EVR(ld) + CsA + Pred |
196 (32.7) 194 (36.6) 193 (29.5) |
65.8 63.4 70.5 |
100 100 100 |
45.9 51.5 52.3 |
CAD:18.6 (6.42); LD:1.3 (1.16); CAD:18.8 (6.43); LD:1.2 (1.14) CAD:19.5 (7.18); LD: 1.4 (3.4) |
36.7 (13.81) 38.4 (13.66) 37.4 (13.55) |
43.4 43.7 43.3 |
RCT, Switzerland, multicenter (44), 36 months, funded by Novartis |
3. Mendez (2005) [57] | MMF + TAC + Pred SRL + TAC + Pred |
176 (30.1) 185 (33.5) |
54.0 50.8 |
NR NR |
64.2 63.2 |
19.8 19.1 |
NR NR |
47.8 (12.3) 45.3 (12.4) |
RCT, USA, multicenter (27),open label, 12 months, funded by Fujisawa |
4. Sampaio (2007) [58] | MMF + TAC + Pred SRL+TAC+Pred |
50 (24.0) 50 (38.0) |
54.0 42.0 |
100 100 |
24.0 24.0 |
NR NR |
41.9 (10.5) 41.6 (10.0) |
42.6 (14.2) 37.4 (10.3) |
RCT, Brazil, single center, open label, 12 months, funded by Janssen-Cilag |
5. Tedesco-Silva (2010) [59]; Cibrik (2013) [60] |
MMF EVR EVR(ld) |
277 (31.8) 279 (31.5) 277 (36.5) |
68.6 64.5 69.7 |
100 100 100 |
46.2 45.9 46.6 |
NR NR NR |
41.8 (13.6) 41.1 (13.0) 41.4 (13.9) |
47.2 (12.7) 45.3 (13.4) 45.7 (12.7) |
RCT, Brazil, multicenter, open label, 12 and 24 months, funded by Novartis |
8. CNI vs. CNI vs. TOR-I | |||||||||
1. Ekberg (2007) [61]; Ekberg (2009) [62] |
CsA(sd) + MMF + Ster CsA(ld) + MMF + Ster TAC(ld) + MMF + Ster SRL(ld) + MMF + Ster |
384 (37.7) 408 (33.6) 403 (34.2) 380 (33.3) |
92.1 92.2 94.0 94.2 |
NR NR NR NR |
65.6 64.2 62.8 64.2 |
16.6 (5.5) 16.8 (5.2) 16.5 (5.7) 16.0 (5.8) |
44.6 (15.9) 46.2 (15.1) 45.2 (15.5) 46.0 (14.8) |
45.9 (13.8) 47.2 (13.5) 45.4 (14.7) 44.9 (14.5) |
RCT (12 months) and Cohort (36 months), Sweden, multicenter (15), open label, 12 and 36 months, funded by Hoffman-La Roche |
9. CNI+AMETAB vs. CNI+TOR-I | |||||||||
1.Kumar † (2005) [63] | CsA + MMF CsA + SRL TAC + MMF TAC + SRL |
58 52 50 40 |
AA = 0 N − AA = 89 |
AA = NR Non – AA = NR |
AA = 93 n − AA= 83 |
AA = 15.5 (6.8) n − AA = 15.9 (12.1) |
AA = 42.0 (16.5) N − AA = 42.3 (19.2) |
AA = 52.9 (12.0) n − AA = 53.0 (15.6) |
RCT, USA, single center, 12 months |
10. TOR-I vs. CNI+TOR-I | |||||||||
1. Tedesco-Silva (2010) [64] | SRL SRL+CsA |
102 (36.3) 105 (36.2) |
72.6 62.9 |
98.0 98.1 |
31.4 30.5 |
7.36 (0.99) 7.64 (1.03) |
NR NR |
41.5 40.9 |
RCT, Brazil, multicenter (9), open label, 12 months, funded by Wyeth |
11. CNI+AMETAB vs. CNI vs. AMETAB | |||||||||
1. Gheith (2008) [69] | CsA + AZA + Pred CsA + Pred AZA + Pred |
239 (26.36) 75 (42.67) 130 (26.92) |
NR NR NR |
NR NR NR |
0 0 0 |
NR NR NR |
34.0 (9.2) 34.6 (10.3) 33.3 (10.1) |
30.7 (10.1) 28.1 (10.3) 29.8 (7.9) |
Cohort, Egypt, single Center, 20 years |
12. TOR-I + CNI-Elim vs. TOR-I vs. CNI | |||||||||
1. Flechner (2011) [65] | SRL + TAC-Elim SRL + MMF TAC + MMF |
152 (28.3) 152 (27.6) 139 (41.7) |
75.0 77.0 73.4 |
92.8 91.5 92.1 |
60.5 63.2 64.0 |
17.7 (6.7) 17.3 (5.7) 17.4 (6.3) |
43.2 (13.6) 45.5 (14.9) 44.4 (13.9) |
47.9 (13.3) 50.4 (13.0) 48.4 (13.2) |
RCT, USA, multicenter (65), open-label, 24 months, funded by Wyeth |
Abbreviations: AMETAB, Antimetabolites; CAD, Cadaveric donor; Elim, elimination; LD, Living donor; NHBD, Non-heart beating donor; NR, not reported; Pred, Prednisone; Ster, Steroids; (ld), Low dose; (sd), Standard dose; (hd), High dose. † The study compares AA (African American) and n-AA (non-African American) recipients