Status:
COMPLETED
Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)
Lead Sponsor:
Novartis
Conditions:
Renal Transplantation
Gastrointestinal Problems
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life o...
Eligibility Criteria
Inclusion
- Received kidney transplant at least 3 months prior to study enrollment
- Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
- Receiving MMF for at least 1 month prior to enrollment
Exclusion
- Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS)
- If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
- Acute rejection \< 1 week prior to study enrollment
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00149968
Start Date
April 1 2005
End Date
January 1 2007
Last Update
February 11 2020
Active Locations (2)
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1
Bonn, Germany
2
Novartis
Basel, Switzerland