Status:
UNKNOWN
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
Lead Sponsor:
University Health Network, Toronto
Conditions:
Organ Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions...
Detailed Description
The use of mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantatio...
Eligibility Criteria
Inclusion
- recipients of liver or kidney or heart or lung or kidney/pancreas transplants
- at least 1 month post solid organ transplant
- on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus
- previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy
- age of 18-75 years
Exclusion
- less than 1 month post transplant
- allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept
- unwillingness or inability to give written consent
- pregnant or nursing women, or women planning to become pregnant
- patients with GI symptoms due to reasons other than related to MMF therapy
- active Post Transplant Lymphoproliferative Disease (PTLD)
- significant or uncontrolled concomitant infections or other serious medical problems
- active bacterial, viral or fungal infection
- inability to self-administer the Quality of Life questionnaires
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00611494
Start Date
January 1 2008
End Date
December 1 2009
Last Update
February 17 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Toronto General Hospital - Multi Organ Transplant Program
Toronto, Ontario, Canada, M5G 2N2