Status:
COMPLETED
Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Kidney Transplantation
Eligibility:
All Genders
13-75 years
Phase:
PHASE4
Brief Summary
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in...
Eligibility Criteria
Inclusion
- Males or females 13-75 years of age
- Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
- Receiving first or second kidney transplant
Exclusion
- Immunosuppressive therapy (except for 48 hours prior to transplantation and corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
- History of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT00087581
Start Date
June 1 2004
End Date
September 1 2007
Last Update
November 7 2016
Active Locations (57)
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1
Birmingham, Alabama, United States, 35294
2
Little Rock, Arkansas, United States, 72205
3
Bakersfield, California, United States, 93309
4
Los Angeles, California, United States, 90048