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

Purpose

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.

Condition	Intervention	Phase
Organ Transplantation	Drug: MMF Drug: EC-MPS	Phase IV

ChemIDplus related topics:

Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Official Title:	A Single Centre, Prospective, Open-Label, Parallel Group, Randomized Study to Compare the Gastrointestinal Tolerability of Mycophenolate Mofetil (MMF, CellCept) and Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic) in Maintenance Transplant Patients Treated With Calcineurin Inhibitors

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: months 3, 6, 12 ] [ Designated as safety issue: Yes ]
Patient survival, graft survival and rejection episodes across the 2 cohorts [ Time Frame: months 3, 6, 12 ] [ Designated as safety issue: No ]
Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events [ Time Frame: Months 6, 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator MMF	Drug: MMF Gradual optimization of drug dosage, as clinically tolerated.
B: Active Comparator EC-MPS	Drug: EC-MPS Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611494

Locations


Canada, Ontario
	Toronto General Hospital - Multi Organ Transplant Program	Recruiting
	Toronto, Ontario, Canada, M5G 2N2
	Contact: Jill Sheedy, RN BScN 416 340 4800 ext 4540 jill.sheedy@uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Investigators


Principal Investigator:	George Therapondos, MD	University Health Network, Toronto

More Information

Responsible Party:	University Health Network ( Dr. George Therapondos )
Study ID Numbers:	07-0398-A
First Received:	January 29, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00611494
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Drug tolerance

Quality of Life

Study placed in the following topic categories:

Mycophenolate mofetil

Mycophenolic Acid

Quality of Life

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00611494