Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors (MOTOR-MPA)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Centre, Prospective, Open-Label, Parallel Group, Randomized Study to Compare the Gastrointestinal Tolerability of Mycophenolate Mofetil (MMF, CellCept) and Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic) in Maintenance Transplant Patients Treated With Calcineurin Inhibitors|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Incidence and severity of adverse events [ Time Frame: months 3, 6, 12 ] [ Designated as safety issue: Yes ]
- Patient survival, graft survival and rejection episodes across the 2 cohorts [ Time Frame: months 3, 6, 12 ] [ Designated as safety issue: No ]
- Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events [ Time Frame: Months 6, 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A
Gradual optimization of drug dosage, as clinically tolerated.
Other Name: CellCept
Active Comparator: B
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
Other Name: Myfortic
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.
|Toronto General Hospital - Multi Organ Transplant Program||Recruiting|
|Toronto, Ontario, Canada, M5G 2N2|
|Contact: Jill Sheedy, RN BScN 416 340 4800 ext 4540 email@example.com|
|Principal Investigator:||George Therapondos, MD||University Health Network, Toronto|