At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 21 enrolled
Drug / intervention
Myforticdrug
Likely dose
Myfortic 720 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetic Profile of Myfortic (Enteric Coated Mycophenolate Sodium) in a Rapid Steroid Withdrawal Protocol in Combination With Tacrolimus in Stable Renal Transplant Recipients in the Fed and Fasting State
In Brief
A Phase 4 clinical trial evaluating Myfortic for Kidney Transplantation. Completed, enrolled 21 participants across 1 site.
Detailed Summary
Literature regarding the effect of food on the pharmacokinetic (PK) profile of enteric-coated mycophenolate sodium combined with tacrolimus and corticosteroid withdrawal is lacking. The objective of this study is to identify pharmacokinetic variables of mycophenolate sodium (Myfortic®) in the fed and fasting state in stable renal transplant patients on tacrolimus in combination with a rapid steroid withdrawal protocol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedJan 2008
Primary CompletionJul 2011
TodayJul 2026
First PostedJan 3, 2008
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.5 years ago
Interventions
Myforticdrug
Myfortic 720 mg orally twice daily