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

University Health Network, Toronto

Status and phase

Unknown

Phase 4

Conditions

Organ Transplantation

Treatments

Drug: EC-MPS

Drug: MMF

Study type

Interventional

Funder types

Other

Identifiers

NCT00611494

07-0398-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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