Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Percentage of participants with reported biopsy proven acute rejection episodes
研究概览
简要总结
This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants greater than 18 years of age
- •Single organ (heart) transplant recipients
- •At risk for post-transplant renal dysfunction
排除标准
- •Previous organ transplant
- •Previous treatment with mycophenolate mofetil, daclizumab or sirolimus
- •Positive for human immunodeficiency virus (HIV) infection
- •History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse
研究组 & 干预措施
Daclizumab + Mycophenolate mofetil
Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram [mg/kg] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily [BID] within first week and 1 grams per day [g/day] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.
干预措施: Daclizumab (Drug)
Daclizumab + Mycophenolate mofetil
Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram [mg/kg] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily [BID] within first week and 1 grams per day [g/day] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.
干预措施: Mycophenolate mofetil (Drug)
Daclizumab + Mycophenolate mofetil
Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram [mg/kg] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily [BID] within first week and 1 grams per day [g/day] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.
干预措施: Silrolimus (Drug)
结局指标
主要结局
Percentage of participants with reported biopsy proven acute rejection episodes
时间窗: up to 6 months
次要结局
- Incidence of adverse events(up to 6 months)
- Incidence of Opportunistic Infections(Up to 5 years post transplant)
- Patient and graft survival(up to 6 months)
- Number of participants with malignancies(up to 6 months)