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Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC* | Clinical Trials | Clareo Health

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

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

NCT00715468•Maisonneuve-Rosemont Hospital

View on ClinicalTrials.gov

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.

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\* .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Key Dates

Start Date

August 1, 2007

Primary Completion Date

December 1, 2013

Completion Date

April 1, 2014

Last Updated

December 12, 2014

Enrollment

ACTUAL participants

Conditions

Late Complication From Kidney Transplant

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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