Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 761
- 试验地点
- 87
- 主要终点
- Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
研究概览
简要总结
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
详细描述
According to protocol amendment of 16 October 2010 Austria is participating in this study.
Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis.
Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.
Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease
- •Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study
排除标准
- •The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply
- •An additional exclusion criterion is a parathyroid hormone- value of > 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol
结局指标
主要结局
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
时间窗: Up to 12 months
Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
时间窗: Up to 12 Months
Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
次要结局
- Mean Duration of Hospitalization by Visit(Months 0, 3, 6, 9, and 11)
- Number of Participants With Hypercalcemia(Months 0, 3, 6, 9, and 12)
- Number of Participants With Hyperphosphatemia(Months 0, 3, 6, 9, and 12)
- Number of Participants With Elevated Calcium-Phosphorus Product(Months 0, 3, 6, 9, and 12)
- Mean Duration of Disability by Visit(Months 0, 3, 6, 9, and 11)
- Mean Calcium-Phosphate Product Levels by Visit(Months 0, 3, 6, 9, and 12)
- Mean Intact Parathormone (iPTH) Levels by Visit(Months 0, 3, 6, 9, and 12)