Safety and Efficacy Study of Rituximab in Renal Transplantation

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Rituximab

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