NCT00646737已完成4 期
Phase IV Study of Enteric-coated Mycophenolate Sodium in Combination With Tacrolimus in Renal Transplant Patient
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Mycophenolate sodium
干预措施: Mycophenolate sodium (Drug)
结局指标
主要结局
Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks
时间窗: 8 and 16 weeks
次要结局
- Impact of gastrointestinal symptoms on quality of life. Tolerability of mycophenolate sodium in combination with tacrolimus assessed by OSRS. Safety of mycophenolate sodium in combination with tacrolimus assessed by incidence of adverse events(8 and 16 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant RecipientsKidney TransplantNCT00537862Novartis Pharmaceuticals200
已完成
3 期
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving TacrolimusPrevention of Acute Rejection After Kidney TransplantationNCT00171392Novartis132
已完成
3 期
Myfortic for the Treatment of Non-infectious Intermediate UveitisUveitis, IntermediateNCT01092533STZ eyetrial44
已完成
3 期
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107Renal TransplantNCT00149916Novartis Pharmaceuticals139
撤回
4 期
Enteric Coated Myfortic for Liver Transplant RecipientsLiver TransplantationNCT00167492The University of Texas Health Science Center, Houston