Safety and Efficacy Study of Rituximab in Renal Transplantation

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255593
• Other study ID #: Eudra CT: 2005-001231-29
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2005
• Last updated: November 29, 2007
• Start date: November 2005
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• rituximab

Locations

Country	Name	City	State
Sweden	Transplantation Surgery, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Genberg H, Hansson A, Wernerson A, Wennberg L, Tydén G. Pharmacodynamics of rituximab in kidney allotransplantation. Am J Transplant. 2006 Oct;6(10):2418-28. Epub 2006 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation
Secondary	Renal function at 6 months
Secondary	Incidence of infections
Secondary	Incidence of rituximab-related adverse events
Secondary	Incidence of malignancies