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
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 30, 2007
October 1, 2007
November 18, 2005
November 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation
Secondary Outcomes (4)
Renal function at 6 months
Incidence of infections
Incidence of rituximab-related adverse events
Incidence of malignancies
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Transplantation Surgery, Karolinska University Hospital
Stockholm, 141 86, Sweden
Related Publications (1)
Genberg H, Hansson A, Wernerson A, Wennberg L, Tyden G. Pharmacodynamics of rituximab in kidney allotransplantation. Am J Transplant. 2006 Oct;6(10):2418-28. doi: 10.1111/j.1600-6143.2006.01497.x. Epub 2006 Aug 21.
PMID: 16925569RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gunnar E Tydén, Professor
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 21, 2005
Study Start
November 1, 2005
Study Completion
October 1, 2007
Last Updated
November 30, 2007
Record last verified: 2007-10