NCT00715468

Completed

Prospective, 6 Month, Open Label, Conversion Study From Myco...

Maisonneuve-Rosemont Hospital Source

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Other study identifiers

Sponsor study identifier

CERL080ACA07

Study Type

observational

Actual enrollment (reported)

59

Locations

1 country

Sites

1

Timeline

Study Start

August 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2013

Actual (reported)

Study Completion

April 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 59 participants
Study completion date: April 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 11, 2008
Actual (reported)
First Posted
July 15, 2008
Actual (reported)
Primary Completion
December 2013
Actual (reported)
Study Completion
April 2014
Actual (reported)

Last Updated: December 12, 2014
Status Verified: December 2014
Last Update Submitted: December 11, 2014

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Maisonneuve-Rosemont Hospital
Otherlead
Novartis
Industrycollaborator

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Study Officials

Suzon Collette, Md
Maisonneuve-Rosemont Hospital
PRINCIPAL INVESTIGATOR

Enrollment

59 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

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.

Contact the study team to confirm eligibility.

Primary Completion

December 2013

Actual (reported)

Study Completion

April 2014

Actual (reported)

Last Updated

December 12, 2014

Record last verified: 2014-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00715468
Data provider: ClinicalTrials.gov
Source updated: 2014-12-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:12 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations