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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611494
Recruitment Status : Unknown
Verified February 2009 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : February 11, 2008
Last Update Posted : February 17, 2009
Information provided by:
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Organ Transplantation Drug: MMF Drug: EC-MPS Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: A
Drug: MMF
Gradual optimization of drug dosage, as clinically tolerated.
Other Name: CellCept

Active Comparator: B
Drug: EC-MPS
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
Other Name: Myfortic

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence and severity of adverse events [ Time Frame: months 3, 6, 12 ]
  3. Patient survival, graft survival and rejection episodes across the 2 cohorts [ Time Frame: months 3, 6, 12 ]
  4. Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events [ Time Frame: Months 6, 12 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00611494

Canada, Ontario
Toronto General Hospital - Multi Organ Transplant Program Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Jill Sheedy, RN BScN    416 340 4800 ext 4540   
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: George Therapondos, MD University Health Network, Toronto

Responsible Party: Dr. George Therapondos, University Health Network Identifier: NCT00611494     History of Changes
Other Study ID Numbers: 07-0398-A
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

Keywords provided by University Health Network, Toronto:
Drug tolerance
Quality of Life

Additional relevant MeSH terms:
Mycophenolic Acid
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action