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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00611494
• Date of registration: 29/01/2008
• Prospective Registration: No
• Primary sponsor: University Health Network, Toronto
• Public title: Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors MOTOR-MPA
• Scientific 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
• Date of first enrolment: January 2008
• Target sample size: 400
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00611494
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: George Therapondos, MD
• Affiliation: University Health Network, Toronto

• Name: Jill Sheedy, RN BScN

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Organ Transplantation

Intervention(s)

Drug: EC-MPS

Drug: MMF

Primary Outcome(s)

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(s)

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]

Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events [Time Frame: Months 6, 12]

Patient survival, graft survival and rejection episodes across the 2 cohorts [Time Frame: months 3, 6, 12]

Incidence and severity of adverse events [Time Frame: months 3, 6, 12]

Secondary ID(s)

07-0398-A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors