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

This study is currently recruiting participants.
Verified July 2013 by Maisonneuve-Rosemont Hospital
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Suzon Collette, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT00715468
First received: July 11, 2008
Last updated: July 30, 2013
Last verified: July 2013

July 11, 2008
July 30, 2013
August 2007
January 2014   (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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00715468 on ClinicalTrials.gov Archive Site
  • evaluate the change in the diarrhea GSRS subscale on a per patient basis [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
  • incidence of adverse events and serious events at months 3 an d6 will be evaluated [ Time Frame: month 3 and 6 ] [ Designated as safety issue: No ]
  • Renal function and incidence of acute rejection [ Time Frame: 1-3-6 months ] [ Designated as safety issue: No ]
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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
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
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
65
January 2015
January 2014   (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.
Both
18 Years and older
No
Contact: Lucie Boutin, RN 514-252-3400 ext 4484 lboutin.hmr@ssss.gouv.qc.ca
Canada
 
NCT00715468
CERL080ACA07
No
Suzon Collette, Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
Novartis
Principal Investigator: Suzon Collette, Md Hôpital Maisonneuve-Rosemont
Maisonneuve-Rosemont Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP