Rituximab for Prevention of Rejection After Renal Transplantation
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Our standard immunosuppressive treatment after renal transplantation is a combination of
tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute
rejection within the first six months after transplantation has dropped to about 20%. The
main challenge at present remains to improve long-term outcome by preventing chronic
allograft nephropathy (CAN). Since acute rejection is a strong predictor of CAN, a further
decrease in the incidence of acute rejection can improve the long-term graft survival.
Current strategies to prevent rejection are mainly directed at alloreactive T cells.
Recently, the attention for the role of antibodies in the pathogenesis of acute rejection has
increased. In addition, anti-B cell therapy was shown to be effective in diseases that were
considered to be mainly T cell driven, like rheumatoid arthritis. In the latter case it has
been suggested that anti-B cell antibodies may impair the antigen presenting function of B
cells. We therefore decided to investigate the effectiveness and safety of the anti-B cell
monoclonal antibody rituximab for prophylaxis of acute rejection after renal transplantation.
Study design: Double-blind, placebo controlled intervention study. One group receives a
single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation, and the
other group receives a placebo infusion.
Primary Objective:
To determine the incidence and severity of biopsy-confirmed acute rejection within the first
six months after transplantation.
Secondary Outcomes:
- Renal function as estimated by the endogenous creatinine clearance at 6 months
- Occurrence of chronic allograft nephropathy at 6 months
- Cumulative incidence of infections and malignancies at 6 months
- Medical costs during the first 6 months after transplantation
- Patient and graft survival