Effectiveness Between Daily Versus Pulse Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients: A Randomized Controlled Trial and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 主要终点
- Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.
研究概览
简要总结
Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.
详细描述
ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk
排除标准
- •Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital
研究组 & 干预措施
B: Pulse
B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week
干预措施: Alfacalcidol (Drug)
A: Daily
A: oral daily alfacalcidol treatments total 6 microgram/week
干预措施: Alfacalcidol (Drug)
结局指标
主要结局
Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.
时间窗: 12 week
mean PTH reduction between two groups at the end of the study by unpaired-T test.
次要结局
未报告次要终点