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

December 11, 2014 updated by: Suzon Collette, Maisonneuve-Rosemont Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Evaluate the change in the total gastrointestinal symptom rating scale(GSRS) score at baseline vs 1 month, va 3 month and vs 6 month
Time Frame: 1 month- 3 month-6 month
1 month- 3 month-6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
evaluate the change in the diarrhea GSRS subscale on a per patient basis
Time Frame: at month 6
at month 6
incidence of adverse events and serious events at months 3 an d6 will be evaluated
Time Frame: month 3 and 6
month 3 and 6
Renal function and incidence of acute rejection
Time Frame: 1-3-6 months
1-3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maisonneuve-Rosemont Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suzon Collette, Md, Maisonneuve-Rosemont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CERL080ACA07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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