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Rituximab for Prevention of Rejection After Renal Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hoffmann-La Roche
Astellas Pharma GmbH
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00565331
First received: November 28, 2007
Last updated: January 4, 2013
Last verified: October 2010

November 28, 2007
January 4, 2013
December 2007
December 2013   (final data collection date for primary outcome measure)
Incidence and severity of biopsy-confirmed acute rejection [ Time Frame: First six months after transplantation ] [ Designated as safety issue: No ]
Incidence and severity of biopsy-confirmed acute rejection [ Time Frame: First six months after transplantation ]
Complete list of historical versions of study NCT00565331 on ClinicalTrials.gov Archive Site
  • Renal function as estimated by the endogenous creatinine clearance [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
  • Occurrence of chronic allograft nephropathy [ Time Frame: First 6 months after transplantation ] [ Designated as safety issue: No ]
  • Cumulative incidence of infections and malignancies [ Time Frame: First 6 months after transplantation ] [ Designated as safety issue: Yes ]
  • Patient and graft survival [ Time Frame: First six months after transplantation ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Rituximab for Prevention of Rejection After Renal Transplantation
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

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
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Kidney Transplantation
Drug: Rituximab
single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation
Other Name: Mabthera, Rituxan
  • Active Comparator: 1
    Rituximab
    Intervention: Drug: Rituximab
  • Placebo Comparator: 2
    Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
June 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00565331
RRT06, UMC Radboud RI000131
No
Radboud University
Radboud University
  • Hoffmann-La Roche
  • Astellas Pharma GmbH
Principal Investigator: Luuk Hilbrands, MD Radboud University
Radboud University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP