Safety and Efficacy Study of Rituximab in Renal Transplantation

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

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.

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