Kidney transplant Injury, Occupational Diseases, Poisoning Kidney transplant
Conditions
Interventions
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 as
Sponsors
Novartis Pharmaceuticals Canada Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed