CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 400 enrolled
Drug / intervention
Enteric-coated mycophenolate sodium (EC-MPS) +3 moredrug
Likely dose
Enteric-coated mycophenolate sodium (EC-MPS) 180 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.

Search/NCT00400400
NCT00400400Phase 4Completed
CompareCT.gov

A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance

Novartis Pharmaceuticals·interventional·Posted Nov 16, 2006·Updated Aug 15, 2011

In Brief

A Phase 4 clinical trial evaluating Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil, and 2 other interventions for Renal Transplantation. Completed, enrolled 400 participants across 53 sites.

Detailed Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2006
Enrollment StartOct 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.6 years ago

Interventions

Enteric-coated mycophenolate sodium (EC-MPS)drug

Enteric-coated mycophenolate sodium supplied as 180 mg tablets.

Mycophenolate mofetildrug

Mycophenolate mofetil supplied as 250 mg capsules.

Placebo to mycophenolate sodiumdrug

Placebo to mycophenolate sodium matching tablets.

Placebo to mycophenolate mofetildrug

Placebo to mycophenolate mofetil matching capsules.