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Rituximab for Prevention of Rejection After Renal Transplantation

This study has been completed.
Hoffmann-La Roche
Astellas Pharma GmbH
Information provided by (Responsible Party):
Radboud University Identifier:
First received: November 28, 2007
Last updated: November 9, 2015
Last verified: November 2015

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

Condition Intervention Phase
Kidney Transplantation
Drug: Rituximab
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study on the Efficacy and Safety of the Prophylactic Use of Rituximab, Added to Standard Immunosuppressive Treatment in Comparison With Standard Immunosuppressive Treatment Alone in Renal Transplantation

Resource links provided by NLM:

Further study details as provided by Radboud University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 280
Study Start Date: December 2007
Study Completion Date: June 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Rituximab
single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
Other Name: Mabthera, Rituxan
Placebo Comparator: 2
Drug: Placebo
saline solution


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Renal transplant recipients
  • Signed, dated, and witnessed IRB approved informed consent

Exclusion Criteria:

  • Pregnancy
  • Living donor, who is HLA identical.
  • Hemolytic uremic syndrome as original kidney disease.
  • Focal segmental glomerulosclerosis that had recurred in a previous graft.
  • More than two previously failed grafts and/or PRA > 85%.
  • Previous treatment with anti-CD20 antibodies.
  • Diabetes mellitus that is currently not treated with insulin.
  • Total white blood cell count <3,000/mm3 or platelet count <75,000/mm3.
  • Active infection with hepatitis B, hepatitis C, or HIV.
  • History of tuberculosis
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Please refer to this study by its identifier: NCT00565331

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Hoffmann-La Roche
Astellas Pharma GmbH
Principal Investigator: Luuk Hilbrands, MD Radboud University
  More Information