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

Organ Transplantation Clinical Trial

— MOTOR-MPA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00611494
• Other study ID #: 07-0398-A
• Status: Recruiting
• Phase: Phase 4
• First received: January 29, 2008
• Last updated: February 16, 2009
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• recipients of liver or kidney or heart or lung or kidney/pancreas transplants

• at least 1 month post solid organ transplant

• on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus

• previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy

• age of 18-75 years

Exclusion Criteria:

• less than 1 month post transplant

• allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept

• unwillingness or inability to give written consent

• pregnant or nursing women, or women planning to become pregnant

• patients with GI symptoms due to reasons other than related to MMF therapy

• active Post Transplant Lymphoproliferative Disease (PTLD)

• significant or uncontrolled concomitant infections or other serious medical problems

• active bacterial, viral or fungal infection

• inability to self-administer the Quality of Life questionnaires

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Organ Transplantation

Intervention

Drug:
• MMF
Gradual optimization of drug dosage, as clinically tolerated.
• EC-MPS
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.

Locations

Country	Name	City	State
Canada	Toronto General Hospital - Multi Organ Transplant Program	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period		12 months	No
Secondary	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.		At months 1, 3, 6, 12 post-study start	No
Secondary	Incidence and severity of adverse events		months 3, 6, 12	Yes
Secondary	Patient survival, graft survival and rejection episodes across the 2 cohorts		months 3, 6, 12	No
Secondary	Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events		Months 6, 12	Yes