NCT06126016招募中不适用
A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.(Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease (CKD 5D) Receiving Hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information.
- •Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study.
- •Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.
排除标准
- •Those with a history of hypersensitivity reactions to this drug or its components
- •Those with evidence of vitamin D toxicity
- •Those with hypercalcemia at enrollment
- •Pregnant or lactating women
- •Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy.
- •Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).
- •Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
结局指标
主要结局
Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)
时间窗: 12 weeks after administration
次要结局
- Incidence of anemia(From baseline to 12 weeks or 24 weeks)
- Change in intact parathyroid hormone(12, 24 weeks compared to pre-dose)
- Change in Calcium X Phosphorus(12, 24 weeks after administration)
- Proportion of subjects whose intact parathyroid hormone level applies to the therapeutic area(CKD 5D)(24 weeks after administration)
- Proportion of subjects whose intact parathyroid hormone level decreased by more than 30%(12, 24 weeks compared to pre-dose)
研究者
研究点 (1)
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