NCT00788567已完成3 期
A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 主要终点
- Proportion of patients achieving therapeutic window by Day 5\n
研究概览
简要总结
This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >=18 years of age;
- •recipients of a primary kidney transplant.
排除标准
- •positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
- •positive for hepatitis C virus, with moderate or severe liver disease;
- •active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
- •need for maintenance corticosteroids for another condition.
研究组 & 干预措施
1
Experimental
干预措施: mycophenolate mofetil (Drug)
结局指标
主要结局
Proportion of patients achieving therapeutic window by Day 5\n
次要结局
- Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n
研究者
相似试验
已完成
4 期
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.Liver TransplantationNCT00545402Hoffmann-La Roche180
已完成
4 期
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.Kidney TransplantationNCT00758602Hoffmann-La Roche210
已完成
4 期
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.Liver TransplantationNCT00717314Hoffmann-La Roche87
已完成
3 期
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)Pemphigus Vulgaris (PV)NCT00683930Hoffmann-La Roche96
已完成
3 期
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.Heart TransplantationNCT02091414Hoffmann-La Roche36