At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 94 enrolled
Drug / intervention
Enteric-coated mycophenolate sodium (EC-MPS) +2 moredrug
Likely dose
Corticosteroids 5 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.
A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus Standard Dose, in Maintenance, Stable, Adult, Kidney Transplant Recipients
In Brief
A Phase 3 clinical trial evaluating Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, and 1 other intervention for Kidney Diseases. Completed, enrolled 94 participants across 1 site.
Detailed Summary
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesSwitzerland
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedFeb 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedFeb 1, 2006
Enrollment StartDec 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.4 years ago
Interventions
Enteric-coated mycophenolate sodium (EC-MPS)drug
Tacrolimusdrug
Corticosteroidsdrug
At a dose of at least 5 mg/day.