Safety and Efficacy Study of Rituximab in Renal Transplantation
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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.
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
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Pregnant or lactating females
Women of childbearing potential not willing to use reliable form of contraception