Original Article
Alemtuzumab and Sirolimus in Renal Transplantation: Six-Year Results of a Single-Arm Prospective Pilot Study

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mTOR inhibitors avoid calcineurin nephrotoxicity, but sirolimus de novo is associated with unacceptable side effects and higher rejection rates. We have investigated a modified strategy: alemtuzumab induction with tacrolimus and mycophenolate maintenance, switching from tacrolimus to sirolimus at 6 months and stopping mycophenolate at 12 months. Here, we report the 6-year follow-up of 30 patients prospectively recruited to this single-arm pilot study and compare outcomes to a matched contemporaneous control group of 30 patients who received standard induction and calcineurin-inhibitor-based immunosuppression. Six-year patient and graft survival were 83% and 80% (alemtuzumab) versus 77% and 70% (control). Rejection rates in the first 6 months were similar in alemtuzumab (6.6%) and control groups (10%). A higher than expected incidence of rejection in the alemtuzumab group following cessation of mycophenolate at 1 year (17%) was mitigated in later patients by retaining low dose mycophenolate. Mean eGFR was higher in the alemtuzumab group at all time points but not significantly (p = 0.16). Tacrolimus levels in the first 6 months were significantly higher in the contemporaneous control group (p < 0.001). Alemtuzumab induction with initial treatment with tacrolimus enables conversion to sirolimus without the side effects and incidence of acute rejection seen in earlier protocols.

Key words:

Calcineurin inhibitor toxicity
Campath-1H
renal transplantation
sirolimus
steroid-free immunosuppression

Abbreviations

CMV
cytomegalovirus
CNI
calcineurin inhibitor
%cRF
calculated reaction frequency
DBD
donation after brain death
DCD
donation after cardiac death
eGFR
estimated GFR
PTLD
posttransplant lymphoproliferative disorder

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