Rituximab for Prevention of Rejection After Renal Transplantation

Sponsor
Radboud University Medical Center
Study ID
NCT00565331
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Kidney Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
  • Placebo — DRUG
    saline solution

Study Details

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

Key Dates

Start date
Dec 31, 2007
Status verified
Nov 2015
Primary completion
Dec 31, 2013
Completion
Jun 30, 2015

Study Design

Enrollment
280 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Rituximab
  • Placebo Comparator: 2
    Placebo

Primary Outcome Measure

Incidence and severity of biopsy-confirmed acute rejection [ Time Frame: First six months after transplantation ]

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