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Switch from EC-MPS to CellCept in Kidney Transplant
NCT00420472Phase 4
Key facts
- Status
- Terminated
- Start
- Mar 2007
- Countries
- 1
- Sponsor
- Roche
- Modality
- Small Molecules
- Conditions
- kidney transplant rejection
01
Overview
Phase 4, open-label, single-arm trial of mycophenolate mofetil in kidney transplant rejection, sponsored by Roche. Primary endpoints: Gastrointestinal Quality of Life Index at 3 months and Gastrointestinal Symptom Rating Scale at 3 months. Started Mar 2007; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Switch Group
Patients switched from reduced dose EC-MPS to CellCept
03
Who it enrols
Adult kidney transplant recipients (1st or 2nd) on stable EC-MPS therapy for >=6 months who are on a lower than recommended dose (<1440 mg/day) due to gastrointestinal complaints.
04
Endpoints
Primary
Gastrointestinal Quality of Life Index
Gastrointestinal Symptom Rating Scale
Secondary
Mean dose increase of CellCept
Pharmacokinetic parameters
Adverse Events
Acute rejection episodes
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