ISRCTN72965183已完成不适用
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:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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