Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 994
- 试验地点
- 69
- 主要终点
- Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
研究概览
简要总结
The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.
详细描述
This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. Follow up visits will occur 1, 3, 6, 9, and 12 months after screening.
研究设计
- 研究类型
- Observational
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
- •Patients 18 years of age or older
- •Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
- •Patients with Intact Parathyroid Hormone (iPTH) > 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) > 110 pg/mL and with chronic kidney disease (CKD) stage 4
- •Patients clinically indicated for treatment with Zemplar capsules
- •Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed
排除标准
- •Patients with clinically important hypercalcemia = Calcium > 2.6 mmol/L (10.5 mg/dL)
- •Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product
结局指标
主要结局
Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
时间窗: From Baseline up to 12 Months
Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
时间窗: From Baseline up to 12 Months
The percentage of participants with Calcium x Phosphorus Product (CxP) values \> 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.
次要结局
- Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)(From Baseline up to 12 Months)
- Percentage of Participants With Hypercalcemia(From Baseline up to 12 months)
- Mean Weekly Dose of Zemplar (Paricalcitol)(From Baseline up to 12 months)
- Number of Participants With Adverse Events (AEs)(Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months))