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

January 29, 2008
February 16, 2009
January 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00611494 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
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 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Organ Transplantation
  • Drug: MMF
    Gradual optimization of drug dosage, as clinically tolerated.
    Other Name: CellCept
  • Drug: EC-MPS
    Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
    Other Name: Myfortic
  • Active Comparator: A
    MMF
    Intervention: Drug: MMF
  • Active Comparator: B
    EC-MPS
    Intervention: Drug: EC-MPS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Not Provided
Canada
 
NCT00611494
07-0398-A
No
Dr. George Therapondos, University Health Network
University Health Network, Toronto
Not Provided
Principal Investigator: George Therapondos, MD University Health Network, Toronto
University Health Network, Toronto
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP