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

Late Complication From Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715468
• Other study ID #: CERL080ACA07
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: December 11, 2014
• Start date: August 2007
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

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* .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Late Complication From Kidney Transplant

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	evaluate the change in the diarrhea GSRS subscale on a per patient basis		at month 6	No
Secondary	incidence of adverse events and serious events at months 3 an d6 will be evaluated		month 3 and 6	No
Secondary	Renal function and incidence of acute rejection		1-3-6 months	No