Status:
COMPLETED
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Kidney Transplantation
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE4
Brief Summary
This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized ...
Eligibility Criteria
Inclusion
- adult patients, \<=75 years of age;
- single organ recipients of renal allograft;
- negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.
Exclusion
- severe gastrointestinal disease which may influence the absorption of oral drug therapy;
- severe infection, HIV or active hepatitis;
- active gastric ulcers;
- malignancy other than cured skin cancer;
- severe anemia, leucopenia or thrombocytopenia.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00758602
Start Date
September 1 2008
End Date
February 1 2011
Last Update
August 4 2014
Active Locations (6)
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1
Beijing, China, 100020
2
Fuzhou, China, 350025
3
Guangzhou, China, 510080
4
Nanjing, China, 210008