Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/01/2007
Date assigned
11/01/2008
Last edited
09/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mina Matsuda-Abedini

ORCID ID

Contact details

BC Children's Hospital
K4-149 Ambulatory Care Building
4480 Oak Street
Vancouver
B.C.
V6H 3V4
Canada
mmatsuda@cw.bc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Myfortic

Study hypothesis

To determine whether pediatric renal transplant recipients experience any difference in their gastrointestinal symptoms when converted from Mycophenolate MoFetil (MMF or CellCept) to Enteric-coated Mycophenolate Sodium (EC-MPS or Myfortic). Also, to evaluate the pharmacokinetics of MycoPhenolic Acid (MPA) in a subgroup of children converting from Cellcept to Myfortic.

Ethics approval

University of British Columbia Clinical Research Ethics Board, approved on 27 November 2007 (ref: H06-03867)

Study design

Non-randomised controlled trial.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Kidney transplant

Intervention

Once consent has been obtained from the participants, they will be asked to complete the validated Gastrointestinal Symptom Rating Scale (GSRS), a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. A subgroup of patients (10 participants) will participate in the pharmacokinetic evaluations.

Intervention: Switch those currently taking MMF (orally) to EC-MPS/ Myfortic (orally) for 6 months. The dose of EC-MPS for each participant will be determined according to the dose of MMF he has been taking.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To determine whether pediatric renal transplant recipients experience any difference in their gastrointestinal symptoms when converted from MMF (CellCept) to EC-MPS (Myfortic) at 6 months.

Secondary outcome measures

To evaluate safety and efficacy of converting pediatric renal transplant patients from MMF to EC-MPS.
Specifically evaluating:
1. The incidence of adverse events within the study period
2. Renal function as determined by serum creatinine and estimated or nuclear Glomerular Filtration Rate (GFR) within the study period
3. Incidence of infections
4. Graft and patient survival within the study period

Overall trial start date

01/12/2006

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children, 7-20 years of age, with renal transplant whose current immunosuppression includes MMF
2. Female patients of childbearing age who agree to maintain effective birth control practice during the study
3. Patient has a functioning renal transplant for at least 3 months and with stable renal function
4. The patient, or in case the patient is minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent to participate in the study. If the minor is in the position to comprehend the nature, significance and scope of the study and to determine his decision accordingly, then his written consent shall also be required. Witnessed informed consent is accepted in case the patient (if not a minor) is capable of making the decision but not capable of signing the document.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Current maintenance immunosuppression does not include Mycophenolate Mofetil
2. The patient has developmental delay or a syndrome that would not allow him or her to complete the GSRS questionnaire
3. Patient with malignancy or history of malignancy
4. Gastrointestinal symptoms not related to MMF (i.e. Infectious diarrhea)
5. Patient has significant, uncontrolled concomitant infections or other serious medical conditions (For example, uncontrolled diabetes or peptic ulcers)
6. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 28 days

Recruitment start date

01/12/2006

Recruitment end date

01/12/2008

Locations

Countries of recruitment

Canada

Trial participating centre

BC Children's Hospital
Vancouver, B.C.
V6H 3V4
Canada

Sponsor information

Organisation

Novartis Pharmaceuticals Canada Inc.

Sponsor details

385 Bouchavrd Blvd.
Dorval
Quebec
H9S 1A9
Canada

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Novartis Phamarceuticals Canada Inc (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes