Status:
COMPLETED
Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC*
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
Novartis
Conditions:
Late Complication From Kidney Transplant
Eligibility:
All Genders
18+ years
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 alter...
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 conversio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00715468
Start Date
August 1 2007
End Date
April 1 2014
Last Update
December 12 2014
Active Locations (1)
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1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4