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

NCT ID: NCT00715468

Last Updated: 2014-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2014-04-30

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.

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* .

Conditions

Late Complication From Kidney Transplant

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suzon Collette

Transplantation Nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzon Collette, Md

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CERL080ACA07

Identifier Type: -

Identifier Source: org_study_id