Clinical trial NCT00715468: Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC*
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Late Complication From Kidney Transplant
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-07-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms

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.

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\* .

Eligibility 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.

Primary outcomes:
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
timeFrame: 1 month- 3 month-6 month
Secondary outcomes:
measure: evaluate the change in the diarrhea GSRS subscale on a per patient basis
timeFrame: at month 6
measure: incidence of adverse events and serious events at months 3 an d6 will be evaluated
timeFrame: month 3 and 6
measure: Renal function and incidence of acute rejection
timeFrame: 1-3-6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Suzon Collette, Md
role: PRINCIPAL_INVESTIGATOR
References: