Organ Transplantation
Conditions
Keywords
Drug tolerance, Quality of Life
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.
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.
Interventions
DRUGMMF
Gradual optimization of drug dosage, as clinically tolerated.
DRUGEC-MPS
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. | At months 1, 3, 6, 12 post-study start |
| Incidence and severity of adverse events | months 3, 6, 12 |
| Patient survival, graft survival and rejection episodes across the 2 cohorts | months 3, 6, 12 |
| Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events | Months 6, 12 |
Countries
Canada
Outcome results
None listed