Table 2.
Study (year) | N | Immunological risk status | rATG regimen | Comparator group/s | Maintenance immunosuppression | Follow-up | Treatment group |
Patient survival (%) |
Graft survival (%) |
Acute rejection (%)a |
---|---|---|---|---|---|---|---|---|---|---|
rATG vs. IL-2RA induction | ||||||||||
Brennan et al. (2006) [24] | 278 | High |
Total dose 7.5 mg/kg/day (days 0–4) |
Basiliximab |
CsA by day 4 MMF Steroids |
12 months | rATG | 95.7 | 90.8 | 15.6 |
IL-2RA | 95.6 | 89.8 | 25.5 | |||||||
p-Value | 0.90 | 0.68 | 0.02 b | |||||||
Ciancio et al. (2005) [92] | 60 | Low |
Total dose 7.0 mg/kg/day (days 0–7) |
Daclizumab |
Tacrolimus MMF Steroids |
Median 15 months |
rATG | 92 | 88 | 16.6 |
IL-2RA | 88 | 88 | 16.6 | |||||||
p-Value | NS | NS | 0.99 | |||||||
Abou-Ayache et al. (2008) [93] | 109 | Low |
1.0–1.5 mg/kg 4–9 infusions |
Daclizumab |
Delayed CsA MMF Steroids |
12 months | rATG | 98 | 95 | 14.5 |
IL-2RA | 98 | 94 | 16.7 | |||||||
p-Value | NS | NS | NS | |||||||
Mourad et al. (2004) [72] | 105 | Low |
1.0 mg/kg Mean 5.4 infusions |
Basiliximab |
Delayed CsA MMF Steroids |
12 months | rATG | 98.1 | 96.2 | 9.4 |
IL-2RA | 98.1 | 94.2 | 9.6 | |||||||
p-Value | NS | NS | NS | |||||||
Steroid-sparing vs. standard steroid regimen | Steroid regimen | |||||||||
Woodle et al. (2009) [94] | 151 | Low | Total dose 5–6 mg/kg | Steroid withdrawal by day 8 |
Tacrolimus MMF |
12 months | Withdrawal | 98.9 | 98.9 | 13.9 |
Standard | 100 | 100 | 19.4 | |||||||
p-Value | NS | NS | NS | |||||||
CNI-free vs. standard CNI regimens | CNI regimen | |||||||||
Glotz et al. (2010) [48] | 141 | Standard |
1.25–1.5 mg/kg 4 dosesc |
CNI free |
Sirolimus MMF Steroids |
12 months | CNI free | 95.8 | 85.9 | 16.9 |
Tacrolimus |
MMF Steroids |
CNI | 97.1 | 95.7 | 12.9 | |||||
p-Value | NS | 0.044 | NS | |||||||
Büchler et al. (2007) [49] | 145 | Standard |
Total dose 7.5 mg/kg/day (days 0–4) |
CNI free |
MMF Steroids (to month 6) |
12 months | CNI free | 97 | 90 | 14.3 |
CsA |
MMF Steroids (to month 6) |
CNI | 97 | 93 | 8.6 | |||||
p-Value | NS | NS | 0.30 | |||||||
Larson et al. (2006) [50] | 165 | Standard |
Total dose 7.5 mg/kg/day (days 0–4) |
Sirolimus |
Sirolimus MMF Steroids |
12 months | CNI free | 98 | 94 | 19 |
Tacrolimus |
MMF Steroids |
CNI | 96 | 92 | 14 | |||||
p-Value | NS | NS | NS | |||||||
Lo et al. (2004) [51] | 70 | High | Total dose 4.5–10.5 mg/kg | CNI free |
Sirolimus MMF Steroids |
12 months | CNI free | 100 | 89 | 7 |
Low CNI |
Sirolimus Reduced tacrolimus Steroids |
Low CNI | 98 | 80 | 10 | |||||
p-Value | NS | NS | NS |
Significant p-values are shown in bold
CNI calcineurin inhibitor, CsA cyclosporine, DGF delayed graft function, IL-2RA interleukin-2 receptor antagonist, MMF mycophenolate mofetil, NS not significant, rATG rabbit antithymocyte globulin
aOr biopsy-proven acute rejection
bSteroid-resistant acute rejection: 1.4 % with Thymoglobulin®, 8.0 % with IL-2RA induction (p = 0.005)
cOnly given to tacrolimus-treated patients in the event of DGF