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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00715468

Enrollment

Registered

2008-07-15

Start date

2007-08-31

Completion date

2014-04-30

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late Complication From Kidney Transplant

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\* .

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Evaluate the change in the total gastrointestinal symptom rating scale(GSRS) score at baseline vs 1 month, va 3 month and vs 6 month	1 month- 3 month-6 month

Secondary

Measure	Time frame
evaluate the change in the diarrhea GSRS subscale on a per patient basis	at month 6
incidence of adverse events and serious events at months 3 an d6 will be evaluated	month 3 and 6
Renal function and incidence of acute rejection	1-3-6 months

Countries

Canada

Outcome results