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

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid

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