Anti-B cell therapy with rituximab as induction therapy in renal transplantation.
Joosten I, Baas MC, Kamburova EG, et al.Transplant Immunology 2014; 31(4):207-9.
Aims
To investigate the effectiveness and safety of the anti-B cell monoclonal antibody rituximab as induction therapy after renal transplantation. The study also looked at the effects of rituximab on the composition of the peripheral B and T cell repertoires, and how rituximab affects functional aspects of these cells.
Interventions
Patients were randomized to a single intra-operative dose of rituximab (375 mg/m2) or placebo, added to a standard immunosuppressive regimen consisting of tacrolimus, mycophenolate mofetil (MMF), and steroids.
Participants
280 renal transplant patients.
Outcomes
Primary outcomes included biopsy proven acute rejection (BPAR), patient and graft survival, graft function, neutropenia, infections and malignancies. Secondary outcomes included function of B and T cells, function of lymph node B and T cells, T cell activation and cytokine release.
Follow-up
Median 4 years (range 1.6 – 6.4 years)
CET Conclusions
N/A
Data analysis
Per protocol analysis
Trial registration
Not reported.