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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00715468
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : December 12, 2014
Information provided by (Responsible Party):
Suzon Collette, Maisonneuve-Rosemont Hospital

July 11, 2008
July 15, 2008
December 12, 2014
August 2007
December 2013   (Final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00715468 on Archive Site
  • evaluate the change in the diarrhea GSRS subscale on a per patient basis [ Time Frame: at month 6 ]
  • incidence of adverse events and serious events at months 3 an d6 will be evaluated [ Time Frame: month 3 and 6 ]
  • Renal function and incidence of acute rejection [ Time Frame: 1-3-6 months ]
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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
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.
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* .
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample
renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms
Late Complication From Kidney Transplant
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Suzon Collette, Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
Principal Investigator: Suzon Collette, Md Hôpital Maisonneuve-Rosemont
Maisonneuve-Rosemont Hospital
December 2014