CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 134 enrolled
Drug / intervention
Enteric-Coated Mycophenolate Sodium (EC-MPS) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Received kidney transplant
  • ✓Currently receiving immunosuppressive regimen that includes mycophenolate mofetil (MMF)
  • ✓Has GI side effects on standard MMF doses OR on reduced-dose MMF with existing but tolerated/controlled GI side effects
  • ✓At least 18 years of age
Key exclusion· 6
  • ✕GI symptoms assumed or known to be caused by something other than mycophenolate (MPA) therapy (e.g., bisphosphonate-induced or infectious diarrhea)
  • ✕Acute rejection within 1 week prior to enrollment
  • ✕Psychiatric illness (schizophrenia, major depression) that would interfere with study requirements, per investigator judgment
  • ✕Currently undergoing acute medical intervention or hospitalization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00239005
NCT00239005Phase 4Completed
CompareCT.gov

A Study of the Effect of Conversion to Enteric-Coated Mycophenolate Sodium (EC-MPS) on Quality of Life in Patients With Gastrointestinal (GI) Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation (MYQOL)

Novartis Pharmaceuticals·interventional·Posted Oct 14, 2005·Updated Mar 30, 2017

In Brief

A Phase 4 clinical trial evaluating Enteric-Coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) for Renal Transplant. Completed, enrolled 134 participants across 1 site.

Detailed Summary

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplant
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 14, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.7 years ago

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)drug

Mycophenolate Mofetil (MMF)drug