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

ovartis Pharmaceuticals Canada Inc.0 个研究点目标入组 32 人开始时间: 2008年1月11日最近更新: 2015年1月13日

适应症

试验速览

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•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.

•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

发起方

ovartis Pharmaceuticals Canada Inc.