Rituximab as Induction Therapy After Renal Transplantation: A Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety.
van den Hoogen MWF, Kamburova EG, et al.American Journal of Transplantation 2015; 15(2): 407-416.
Aims
To test whether adding a single dose of rituximab to an immunosuppressive regimen consisting of tacrolimus, mycophenolate mofetil and steroids would reduce the incidence of biopsy proven acute renal allograft rejection.
Interventions
Rituximab versus placebo.
Participants
281 renal transplant recipients.
Outcomes
The primary endpoint was the incidence and severity of BPAR within the first 6 months after transplantation. Secondary endpoints included the estimated glomerular filtration rate (eGFR), cumulative incidence of infections and malignancies, and patient and graft survival. All serious adverse events were recorded.
Follow-up
24 months.
CET Conclusions
This is a well-described report of a single centre, randomized, double-blind, placebo-controlled trial of rituximab induction therapy. Sample size calculations showed that 140 participants per arm were needed to have 80% power to detect a reduction in the incidence of rejection from 15% to 5%. 281 patients were randomised. There were no safety concerns with the rituximab infusion and all but six patients received the full dose. When the two arms were compared no difference was found in the rate of biopsy proven acute rejection, delayed graft function and patient and graft survival. However, a subgroup analysis of immunologically low and high risk patients suggested that there may be a potential effect of rituximab for high-risk patients.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT00565331.