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

NCT00611494 | Unknown Phase 4

• 1 other identifier: 07-0398-A
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplantation

Keywords

Drug tolerance; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

A

ACTIVE COMPARATOR

MMF

Drug: MMF

B

ACTIVE COMPARATOR

EC-MPS

Drug: EC-MPS

Interventions

MMF DRUG

Gradual optimization of drug dosage, as clinically tolerated.

Also known as: CellCept

A

EC-MPS DRUG

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

Also known as: Myfortic

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital - Multi Organ Transplant Program

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• George Therapondos, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 17, 2009

Record last verified: 2009-02

Locations

CA (1)