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

University Health Network, Toronto400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Organ Transplantation

Interventions

MMFDRUG

Gradual optimization of drug dosage, as clinically tolerated.

EC-MPSDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Toronto General Hospital - Multi Organ Transplant Program

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Incidence and severity of adverse events

Time frame: months 3, 6, 12

Patient survival, graft survival and rejection episodes across the 2 cohorts

Time frame: months 3, 6, 12

Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events

Time frame: Months 6, 12

Data from ClinicalTrials.gov

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