Does conversion from Mycophenolate Mofetil (CellCept) to Enteric-coated Mycophenolate Sodium (Myfortic) improve gastrointestinal symptoms in pediatric renal transplant recipients?

ISRCTN ISRCTN72965183
DOI https://doi.org/10.1186/ISRCTN72965183
Secondary identifying numbers N/A
Submission date
12/01/2007
Registration date
11/01/2008
Last edited
09/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mina Matsuda-Abedini
Scientific

BC Children's Hospital
K4-149 Ambulatory Care Building
4480 Oak Street
Vancouver, B.C.
V6H 3V4
Canada

Email mmatsuda@cw.bc.ca

Study information

Study designNon-randomised controlled trial.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymMyfortic
Study objectivesTo 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(s)University of British Columbia Clinical Research Ethics Board, approved on 27 November 2007 (ref: H06-03867)
Health condition(s) or problem(s) studiedKidney transplant
InterventionOnce 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 typeOther
Primary outcome measureTo 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 measuresTo 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 study start date01/12/2006
Completion date01/12/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit20 Years
SexBoth
Target number of participants32
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/12/2006
Date of final enrolment01/12/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

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

Sponsor information

Novartis Pharmaceuticals Canada Inc.
Industry

385 Bouchavrd Blvd.
Dorval
Quebec
H9S 1A9
Canada

ROR logo "ROR" https://ror.org/05afs3z13

Funders

Funder type

Industry

Novartis Phamarceuticals Canada Inc (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan