Status:
COMPLETED
Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
Lead Sponsor:
Dr. Claudia Bösmüller
Collaborating Sponsors:
Astellas Pharma GmbH
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for C...
Detailed Description
Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinations.However, these combinations carry the risk of e.g. infection, malignancy, ...
Eligibility Criteria
Inclusion
- age 18-65
- endstage renal failure with no previous renal transplantation
- cadaveric donor
- written informed consent
Exclusion
- pregnant or nursing women
- multi-organ transplant recipients
- live donor recipients
- re-transplants
- panel reactive antibodies (PRA) \> 25%
- previous treatment with Campath-1H
- use of other investigational agents within 6 weeks
- active systemic infection
- HIV positive patient or donor
- positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells
- past history of anaphylaxis following exposure to humanized monoclonal antibodies
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00147381
Start Date
January 1 2004
End Date
July 1 2011
Last Update
June 19 2012
Active Locations (1)
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1
University Hospital Innsbruck
Innsbruck, Tyrol, Austria, 6020