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

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ClinicalTrials.gov Identifier: NCT00715468
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : December 12, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Suzon Collette, Maisonneuve-Rosemont Hospital

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715468


Locations
Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Novartis
Investigators
Principal Investigator: Suzon Collette, Md Hôpital Maisonneuve-Rosemont
More Information
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Responsible Party: Suzon Collette, Transplantation Nephrologist, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT00715468     History of Changes
Other Study ID Numbers: CERL080ACA07
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014