Safety and Efficacy Study of Rituximab in Renal Transplantation

Phase 1

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00255593
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-21
• Status Verified: 2007-10
• Study Completion: 2007-10
• Last Update Submitted: 2007-11-29
• Last Update Posted: 2007-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation

Secondary Outcome Measures

Name	Time	Method
Renal function at 6 months
Incidence of infections
Incidence of rituximab-related adverse events
Incidence of malignancies

Trial Locations

Locations (1)

Transplantation Surgery, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden