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
Scientific
BC Children's Hospital
K4-149 Ambulatory Care Building
4480 Oak Street
Vancouver, B.C.
V6H 3V4
Canada
| mmatsuda@cw.bc.ca |
Study information
| Study design | Non-randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/12/2006 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 20 Years |
| Sex | Both |
| Target number of participants | 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
V6H 3V4
Canada
Sponsor information
Novartis Pharmaceuticals Canada Inc.
Industry
Industry
385 Bouchavrd Blvd.
Dorval
Quebec
H9S 1A9
Canada
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
