Status:
COMPLETED
Safety and Efficacy Study of Rituximab in Renal Transplantation
Lead Sponsor:
Karolinska University Hospital
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00255593
Start Date
November 1 2005
End Date
October 1 2007
Last Update
November 30 2007
Active Locations (1)
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1
Transplantation Surgery, Karolinska University Hospital
Stockholm, Sweden, 141 86