A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 61
- 主要终点
- Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
研究概览
简要总结
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months post-transplant
- •At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
- •Receiving stable doses of cyclosporine microemulsion for the past 3 months
排除标准
- •- Severe rejection within the past 3 months
- •Severe kidney dysfunction
- •Transplanted for hepatitis C or autoimmune hepatitis
- •Other protocol-defined exclusion criteria applied
研究组 & 干预措施
BID cyclosporine
control group continuing with a BID administration of cyclosporine and C2 monitoring.
干预措施: Cyclosporine microemulsion (Drug)
OAD cyclosporine
conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion
干预措施: Cyclosporine microemulsion (Drug)
OAD cyclosporine reduced
OAD administration of cyclosporine with a daily dose adjusted to a reduced C2
干预措施: Cyclosporine microemulsion (Drug)
结局指标
主要结局
Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
次要结局
- assess the safety of a once a day administration of cyclosporine microemulsion.
- compare for each patient the C2 levels pre- and post-conversion.
- characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
- the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually)(4 months)