Status:
COMPLETED
MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients
Lead Sponsor:
Ekberg, Henrik, M.D.
Collaborating Sponsors:
Prof. Philip Halloran, Edmonton, Canada (sponsor)
Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member)
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainsta...
Detailed Description
The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens. They are each given for one year. The following four combinations are tested in four groups of patients: * G...
Eligibility Criteria
Inclusion
- Male or female patients between 18 - 75 years
- Recipients of single-organ renal primary allograft or second renal transplants (provided that the previous graft was not lost from acute rejection within the first year) from living or cadaver donors
- Patients who provide written informed consent.
Exclusion
- PRA \> 20% within 6 months prior to enrollment
- Cold ischemia time \> 30 hours
- Previous treatment with daclizumab
- History of malignancy (except localized skin cancer)
- Active peptic ulcer disease.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
1760 Patients enrolled
Trial Details
Trial ID
NCT00231764
Start Date
November 1 2002
End Date
February 1 2008
Last Update
April 24 2008
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