Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
tacrolimus extended release capsules vs Prograf
London Health Sciences Centre
London, Ontario, Canada
renal function
Time frame: baseline to 6 months
Bioequivalence of MPA exposure with Advagraf
Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations.
Time frame: Baseline, 12 weeks and 24 weeks
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