Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy-an open label, randomized trial.
Chan K. Taube D et al.Transplantation. 92(7): 774-80, 2011
Aims
To explore whether or not the simple, cheap, regimen of alemtuzumab induction combined with tacrolimus monotherapy maintenance can provide equivalent outcomes to a conventional combination of interleukin-2 receptor monoclonal antibody induction with tacrolimus and mycophenolate mofetil maintenance.
Interventions
Alemtuzumab induction with tacrolimus monotherapy maintenance versus daclizumab induction with combined tacrolimus and mycophenolate mofetil maintenance. All patients received steroid for 7 days. Cytomegalovirus prophylaxis with Valganciclovir and Pneumocystis prophylaxis with Co-Trimoxazole were given to all patients.
Participants
One hundred twenty-three renal transplant recipients.
Outcomes
The primary endpoint was survival with a functioning graft at 1 year posttransplant. Secondary endpoints were the incidence and histological type of biopsy-proven acute rejection episodes and episodes of infection, graft function, the incidence of new-onset diabetes, and patient and graft outcomes at 2 years. Adverse events included death, episodes of rejection, infection, or graft dysfunction due to drug toxicity. Serious adverse events included death, life threatening infection and graft failure.
Follow-up
2 years.
CET Conclusions
Induction with alemtuzumab followed by tacrolimus monotherapy and a short course of steroids was as effective as a more conventional immunosuppressive regimen comprising daclizumab, tacrolimus, mycophenolate and steroids.
Data analysis
Available case analysis
Trial registration
Trial registration: ClinicalTrials.gov (NCT00246129).