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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00611494
First received: January 29, 2008
Last updated: February 16, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Organ Transplantation
 Drug: MMF
Drug: EC-MPS
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
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)
Arms Assigned Interventions
Active Comparator: A
MMF
 Drug: MMF
Gradual optimization of drug dosage, as clinically tolerated.
Other Name: CellCept
Active Comparator: B
EC-MPS
 Drug: EC-MPS
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
Other Name: Myfortic

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611494

Locations
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     jill.sheedy@uhn.on.ca    
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: George Therapondos, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. George Therapondos, University Health Network
ClinicalTrials.gov Identifier: NCT00611494     History of Changes
Other Study ID Numbers: 07-0398-A
Study First Received: January 29, 2008
Last Updated: February 16, 2009
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Mycophenolate mofetil
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013