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
|
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Condition or disease |
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Late Complication From Kidney Transplant |
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 |
- 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 ]
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Canada, Quebec | |
Hôpital Maisonneuve-Rosemont | |
Montréal, Quebec, Canada, H1T 2M4 |
Principal Investigator: | Suzon Collette, Md | Hôpital Maisonneuve-Rosemont |
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 |