Safety and Efficacy Study of Rituximab in Renal Transplantation
- Sponsor
- Karolinska University Hospital
- Study ID
- NCT00255593
- Phase
- PHASE1
- Status
- Completed
Conditions
- Renal Transplantation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — DRUG
Study Details
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.
Key Dates
- Start date
- Nov 30, 2005
- Status verified
- Oct 2007
- Completion
- Oct 31, 2007
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Primary Outcome Measure
Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation