Recruiting

MMF vs. EC-MPS

Sponsor:

University Health Network, Toronto

Code:

NCT00611494

Conditions

Organ Transplantation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MMF

EC-MPS

Study Details

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

Study ID

NCT00611494

Start date

Jan, 2008

Status verified date

Feb, 2009

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: A

MMF

active comparator: B

EC-MPS

Interventions

MMF

Gradual optimization of drug dosage, as clinically tolerated.

EC-MPS

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Toronto General Hospital - Multi Organ Transplant Program

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Jill Sheedy, RN BScN

416 340 4800jill.sheedy@uhn.on.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 17, 2009

Last verified

Feb, 2009

Keywords

  • Drug tolerance
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2009-02-17.