A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Confirmed Hypercalcemia
研究概览
简要总结
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.
详细描述
General Design
- Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
- Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
- Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paricalcitol
titrated to achieve 40-60% PTH suppression
干预措施: Paricalcitol (Drug)
Calcitriol
titrated to achieve 40-60% PTH suppression
干预措施: Calcitriol (Drug)
结局指标
主要结局
Confirmed Hypercalcemia
时间窗: 24 week treatment period
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
次要结局
未报告次要终点
研究者
Daniel W. Coyne
Professor of Medicine
Washington University School of Medicine