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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list