A Phase 4 interventional study of MMF and EC-MPS in Organ Transplantation, sponsored by University Health Network, Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-02-17.
Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Treatment
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.
The use of mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantation patients. However, its use has been associated with significant side effects, including gastrointestinal complications, causing dose reductions, interruption or termination of the therapy. An alternate formulation: enteric coated mycophenolate sodium (EC-MPS) was designed to alleviate the severity of upper gastrointestinal side effects. Several trials detailed in the protocol suggest a benefit in GI related health following conversion from MMF to EC-MPS, however we believe that robust data are lacking.
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MMF
Drug: MMF
EC-MPS
Drug: EC-MPS
Gradual optimization of drug dosage, as clinically tolerated.
Also known as: CellCept
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
Also known as: Myfortic
The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period
Time frame: 12 months
Analysis and comparison of various Gastrointestinal Symptom Rating and Quality of Life Questionnaire (the GSRS, GIQLI, PGWB,OTE for HRQoL) scores across and within the 2 cohorts.
Time frame: At months 1, 3, 6, 12 post-study start
Incidence and severity of adverse events
Time frame: months 3, 6, 12
Patient survival, graft survival and rejection episodes across the 2 cohorts
Time frame: months 3, 6, 12
Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events
Time frame: Months 6, 12
This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto