drugset / Trial / NCT00611494

Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors

NCT00611494

Phase 4 Unknown 400 enrolled University Health Network, Toronto
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions of 25% or more due to GI complications. The tested hypothesis is that the EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.

Timeline

Start
2008-01
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule
Comparator mycophenolic acid Small molecule