Status:
COMPLETED
Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation pro...
Eligibility Criteria
Inclusion
- Males or females, 18 to 65 years old
- First or second time kidney transplant patients
- For females capable of becoming pregnant, negative pregnancy test prior to entry into trial and effective birth control during trial and 3 months after stopping trial medication
Exclusion
- Previous graft loss due to immunological reasons in the 1st year after the 1st transplant
- Multi-organ recipients or previous transplant of another organ, different from the kidney
- Recipients from a non-heart-beating donor
- Known hypersensitivity to mycophenolic acid or cyclosporine
- HIV positive or Hepatitis B surface antigen positive
- History of malignancy (past 5 years)
- Pregnancy or planned pregnancy, lactating, or unwillingness to use effective contraception.
- Evidence of severe liver disease
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00419926
Start Date
December 1 2006
End Date
June 1 2009
Last Update
March 1 2011
Active Locations (1)
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1
Novartis
Basel, Switzerland