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

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: Completed
• Conditions: Late Complication From Kidney Transplant

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: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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	1 month- 3 month-6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
evaluate the change in the diarrhea GSRS subscale on a per patient basis	at month 6
incidence of adverse events and serious events at months 3 an d6 will be evaluated	month 3 and 6
Renal function and incidence of acute rejection	1-3-6 months

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Collaborators: Novartis
• Investigators: Principal Investigator: Suzon Collette, Md, Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 11, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CERL080ACA07