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Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC*

Sponsor
Maisonneuve-Rosemont Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00715468
Collaborator
Novartis (Industry)
59
Enrollment
1
Location
80
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Treatment with MMF often results in adverse GI events, which can lead to dose reductions of MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was developed as an alternative formulation of MPA to improve upper GI tract side effects. An improvement in the severity of GI side effects could result in an increased tolerance to MPA and an improvement in patient quality of life. This study will use the GSRS to evaluate improvement in gastrointestinal symptoms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will evaluate the change in the total gastrointestinal symptom rating scale (GSRS) score at baseline versus month 1,at baseline versus month 3 and at baseline versus month 6 after conversion from MMF to PRMYFORTIC* .

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Prospective, 6 Month, Open Label, Conversion Study From MMF to MYFORTIC* Evaluating the Severity of GI Symptoms and MPA Metabolite as a Surrogate Marker of MYFORTIC
    Study Start Date :
    Aug 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Apr 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the change in the total gastrointestinal symptom rating scale(GSRS) score at baseline vs 1 month, va 3 month and vs 6 month [1 month- 3 month-6 month]

    Secondary Outcome Measures

    1. evaluate the change in the diarrhea GSRS subscale on a per patient basis [at month 6]

    2. incidence of adverse events and serious events at months 3 an d6 will be evaluated [month 3 and 6]

    3. Renal function and incidence of acute rejection [1-3-6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Received a kidney transplant at least six months

    • stable graft function (no increased creatinine > 20% in the previous 4 weeks)

    • Receiving immunosuppressive regimen with stable dose of MMF for at least 4 weeks

    • Immunosuppressive regimen with a dose of MMF (dose≤ 2.0 g/day) at least 4 weeks OR C0 MMF < 1.4 µg/ml at visit 1 OR patients receiving MMF who have GI side effects

    • Willing to provide written informed consent

    • Women of childbearing age must have a negative pregnancy test and use a medically acceptable method of contraception throughout the treatment period;

    • Over 18 years of age.

    Exclusion Criteria:

    • GI symptoms assumed or known not to be caused by MPA therapy;

    • Acute rejection episode ≤ 4 weeks prior to study enrollment;

    • Liver disease interfering with enterohepatic recirculation, such as active hepatitis B, active hepatitis C, autoimmune hepatitis and liver cirrhosis;

    • Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control;

    • Active bacterial, viral or fungal infection;

    • Presence of psychiatric illness that in the view of the investigator would interfere with study requirements;

    • Known sensitivity to the study drug;

    • Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Maisonneuve-Rosemont Montréal Quebec Canada H1T 2M4

    Sponsors and Collaborators

    • Maisonneuve-Rosemont Hospital
    • Novartis

    Investigators

    • Principal Investigator: Suzon Collette, Md, Hôpital Maisonneuve-Rosemont

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suzon Collette, Transplantation Nephrologist, Maisonneuve-Rosemont Hospital
    ClinicalTrials.gov Identifier:
    NCT00715468
    Other Study ID Numbers:
    • CERL080ACA07
    First Posted:
    Jul 15, 2008
    Last Update Posted:
    Dec 12, 2014
    Last Verified:
    Dec 1, 2014

    Study Results

    No Results Posted as of Dec 12, 2014