CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Enteric-coated mycophenolate sodium (EC-MPS)drug
Likely dose
Not stated in 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/NCT00267150
NCT00267150Phase 3Completed
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Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients

Novartis Pharmaceuticals·interventional·Posted Dec 20, 2005·Updated May 20, 2011

In Brief

A Phase 3 clinical trial evaluating Enteric-coated mycophenolate sodium (EC-MPS) for Pancreas Transplantation and Kidney Transplantation. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreas Transplantation, Kidney Transplantation
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2005
Enrollment StartNov 1, 2005
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.5 years ago

Interventions

Enteric-coated mycophenolate sodium (EC-MPS)drug

Experimental