Safety and Efficacy Study of Rituximab in Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255593
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : November 30, 2007
Information provided by:
Karolinska University Hospital

Brief Summary:
Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: rituximab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation
Study Start Date : November 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Primary Outcome Measures :
  1. Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation

Secondary Outcome Measures :
  1. Renal function at 6 months
  2. Incidence of infections
  3. Incidence of rituximab-related adverse events
  4. Incidence of malignancies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 years or above
  • Recipients of first or second renal transplants
  • Recipients of kidneys from living or cadaveric donors
  • Single organ recipients (kidney only)
  • Patients providing written informed consent
  • Patients cooperative and able to complete all the assessment procedures

Exclusion Criteria:

  • Patients receiving other immunosuppressive therapy within the preceding 28 days
  • Recipients of HLA-identical sibling kidneys
  • Patients with flow-PRA >50% within 6 months prior to enrolment
  • Recent history of malignancy
  • Active infection
  • Pregnant or lactating females
  • Women of childbearing potential not willing to use reliable form of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255593

Transplantation Surgery, Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
Study Director: Gunnar E Tydén, Professor Karolinska Institutet

Publications of Results: Identifier: NCT00255593     History of Changes
Other Study ID Numbers: Eudra CT: 2005-001231-29
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: October 2007

Keywords provided by Karolinska University Hospital:

Additional relevant MeSH terms:
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents