Status:
COMPLETED
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pancreas Transplantation
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated ...
Eligibility Criteria
Inclusion
- Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to study enrollment
- Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at least for three months at time of study enrollment)
- Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.
Exclusion
- Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also SCP of EC-MPS)
- If applicable, GI symptoms assumed or known to be induced by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea)
- Acute rejection \< 1 month prior to study enrollment
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00267150
Start Date
November 1 2005
End Date
January 1 2008
Last Update
May 20 2011
Active Locations (1)
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1
Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin
Berlin, Germany, 13353