A Phase 2/3 interventional study of Rituximab and Placebo in Kidney Transplantation, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-10.
Sponsored by Radboud University Medical Center · Phase 2/3, Interventional, and Treatment
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:
Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rituximab
Drug: Rituximab
Placebo
Drug: Placebo
single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
Also known as: Mabthera, Rituxan
saline solution
Incidence and severity of biopsy-confirmed acute rejection
Time frame: First six months after transplantation
Renal function as estimated by the endogenous creatinine clearance
Time frame: 6 months after transplantation
Occurrence of chronic allograft nephropathy
Time frame: First 6 months after transplantation
Cumulative incidence of infections and malignancies
Time frame: First 6 months after transplantation
Patient and graft survival
Time frame: First six months after transplantation
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center