This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (\<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Cologne, Germany
Unnamed facility
Dresden, Germany
Unnamed facility
Gastrointestinal Quality of Life index, and Gastrointestinal Symptom Rating Scale, at 3 months.
Efficacy: Mean dose increase of CellCept. Pharmacokinetics: Comparison of pharmacokinetic parameters under EC-MPS and CellCept therapy. Safety: AEs; acute rejection episodes.
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Essen, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Münster, Germany