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. 2014 Aug 28;74(14):1605–1634. doi: 10.1007/s40265-014-0277-6

Table 2.

Randomized trials of rATG (Thymoglobulin®) induction therapy in kidney transplant patients using contemporary dosing regimens (cumulative dose (≤7.5 mg/kg)

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