NCT00255593

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	rituximab

Timeline

• Start date: 2005-11-01
• Completion: 2007-10-01
• First posted: 2005-11-21
• Last updated: 2007-11-30

Locations

1 site across 1 country: Sweden