Safety and Efficacy Study of Rituximab in Renal Transplantation

Karolinska University Hospital

Status and phase: Completed; Phase 1

Conditions: Renal Transplantation

Treatments: Drug: rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00255593

Eudra CT: 2005-001231-29

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind