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

NCT ID: NCT00611494

Last Updated: 2009-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Organ Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

MMF

Group Type: ACTIVE_COMPARATOR

MMF

Intervention Type: DRUG

Gradual optimization of drug dosage, as clinically tolerated.

B

EC-MPS

Group Type: ACTIVE_COMPARATOR

EC-MPS

Intervention Type: DRUG

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

Interventions

MMF

Gradual optimization of drug dosage, as clinically tolerated.

Intervention Type: DRUG

EC-MPS

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

Intervention Type: DRUG

Other Intervention Names

CellCept; Myfortic

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

University Health Network

Principal Investigators

George Therapondos, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto General Hospital - Multi Organ Transplant Program

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Jill Sheedy, RN BScN

Role: primary

jill.sheedy@uhn.on.ca

416 340 4800 ext. 4540

Other Identifiers

07-0398-A

Identifier Type: -

Identifier Source: org_study_id