Prospective, 6 Month, Open Label, Conversion Study From M... | NCT00715468

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

NCT00715468

Sponsor

Maisonneuve-Rosemont Hospital

Status

Completed

Last Update Posted

Dec 12, 2014Estimated

Enrollment

59Actual

Phase

Not provided

Conditions

Late Complication From Kidney Transplant

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 11, 2008

First Submission Date that Met QC Criteria

Jul 14, 2008

First Posted Date

Jul 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2014

Last Update Posted Date

Dec 12, 2014Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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* .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample