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

NCT00715468 | Completed

• 1 other identifier: CERL080ACA07
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Late Complication From Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Novartis: collaborator

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Study Officials

• Suzon Collette, Md

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplantation Nephrologist

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: August 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

CA (1)