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
Protocol serial number	N/A
Sponsor	Novartis Pharmaceuticals Canada Inc.
Funder	Novartis Phamarceuticals Canada Inc (Canada)

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

Primary study design	Interventional
Study design	Non-randomised controlled trial.
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	Myfortic
Study objectives	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(s)	University of British Columbia Clinical Research Ethics Board, approved on 27 November 2007 (ref: H06-03867)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/12/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	20 Years
Sex	All
Target sample size at registration	32
Key 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.
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	01/12/2008

Locations

Countries of recruitment

Canada

Study participating centre

BC Children's Hospital

Vancouver, B.C.
V6H 3V4
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes