Safety and Efficacy Study of Rituximab in Renal Transplantation

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00255593
First received: November 18, 2005
Last updated: November 29, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Renal Transplantation
Drug: rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

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

Secondary Outcome Measures:
  • Renal function at 6 months
  • Incidence of infections
  • Incidence of rituximab-related adverse events
  • Incidence of malignancies

Estimated Enrollment: 140
Study Start Date: November 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255593

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

Publications:
ClinicalTrials.gov Identifier: NCT00255593     History of Changes
Other Study ID Numbers: Eudra CT: 2005-001231-29
Study First Received: November 18, 2005
Last Updated: November 29, 2007
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska University Hospital:
Kidney
Transplantation
Immunosuppression
Rituximab

Additional relevant MeSH terms:
Mycophenolate mofetil
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014