A Randomized Trial Comparing an Integrated Care Approach Using Electronic Cinacalcet Adherence Data Versus Usual Care to Improve Secondary Hyperparathyroidism in Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Relative change from baseline in cinacalcet dose at 6 months
研究概览
简要总结
Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs.
The main objective of this study was to assess whether an integrated care (IC) approach, in which adherence data are integrated in the decisional process, led to improved therapeutic control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as compared to a usual care (UC) approach, in which biological values represent the main stem of the decisional process.
The predefined hypothesis was that patients of the IC group should reach the iPTH targets using 25% less doses of cinacalcet at 6 months than those of the UC group.
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
- •Age > 18 years
- •Patients on hemodialysis since more than 3 months
- •Patients with secondary hyperparathyroidism treated with Cinacalcet-HCl at a stable dose (30mg/day or more) for at least 1 month before enrolment and indication to Cinacalcet-HCL therapy (iPTH in target values or over target values)
- •Patients with secondary hyperparathyroidism with indication to be treated with Cinacalcet-HCL (iPTH ≥ locally pre-defined targets). In this case, patients should be treated at least 1 month with stable dose Cinacalcet-HCL before enrolment
排除标准
- •Intolerance to Cincalcet-HCL
- •Inability to understand the protocol
- •Mental diseases
- •Patients suffering from cancer or having a short life expectancy (<6 months)
- •Patients planned for a parathyroidectomy
- •Patients having had a parathyroidectomy
- •Patient already enrolled in a Cinacalcet-HCL protocol
- •Symptomatic hypocalcaemia or total serum calcium < 1.87 mmol/l
结局指标
主要结局
Relative change from baseline in cinacalcet dose at 6 months
时间窗: baseline and 6 months
* (6-months dose - baseline dose)/ baseline dose % * dose expressed in mg/d
次要结局
- absolute change from baseline in iPTH at 6 months(baseline and 6 months)
研究者
Michel Burnier
Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois