Alemtuzumab induction in renal transplantation permits safe steroid avoidance with tacrolimus monotherapy: a randomized controlled trial.
Welberry Smith MP, Cherukuri A, et al.Transplantation 2013;96(12):1082-8
Aims
To compare basiliximab induction with alemtuzumab induction in low immunologic risk recipients.
Interventions
Patients received either basiliximab induction and a single dose of i.v. methylprednisolone intraoperatively followed by mycophenolate mofetil (MMF) and tacrolimus or alemtuzumab induction and a single dose of i.v. methylprednisolone followed by tacrolimus monotherapy.
Participants
120 kidney donors.
Outcomes
The primary outcome was non-inferiority of isotopic glomerular filtration rate. The secondary outcomes included patient and graft survival, rates of delayed graft function, severity and rates of rejection, time to rejection, 24h blood pressure rates of cardiovascular, malignant and infective complications, percentage of patients steroid-free at 12 months and rates of new onset diabetes mellitus after transplantation.
Follow-up
1 year.
CET Conclusions
This is a well conducted and described RCT. Alemtuzumab induction therapy, followed by Tacrolimus monotherapy was associated with the same measured GFR (isotope) one year after renal transplantation compared to Basiliximab induction followed by Tacrolimus and Mycophenolate. There was less biopsy proven acute rejection in the Alemtuzumab arm. It should be noted that the study was conducted in a low immune risk population only. The Alemtuzumab arm had a significant reduction in white cell count and haemoglobin. There was no effect on patient survival, graft survival, or overall infection episodes, although the study could have been underpowered for these outcomes.
Data analysis
Modified intention-to-treat analysis
Trial registration
EudraCT – 2006-000830-11