A 18 Months, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Hemodialysis, Receiving sVDRA's for Prevention and Treatment of Secondary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 试验地点
- 22
- 主要终点
- To assess percentage change in iPTH (intact Parathyroid Hormone) level monthly among hemodialysis patients with SHPT (Secondary Hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy
研究概览
简要总结
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.
详细描述
The scientific purpose of this study is to obtain data on the use of sVDRA(Selective Vitamin D Receptor Activator) in real-life clinical practice. This study will allow us to observe drug effectiveness in a distinct geography. Treatment effects, as well as maintenance of the results will be recorded for a 18 months period in order to obtain experience in the long term use of sVDRA(Selective Vitamin D Receptor Activator). Furthermore in the centers, additional blood parameter, hsCRP (high sensitivity C-reactive protein), will be examined as part of the clinical routine.
The primary aim of the study is:
- To assess percentage change in iPTH (intact parathyroid hormone) level monthly among hemodialysis patients with sHPT (secondary hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy.
Secondary aims are:
- To observe changes in commonly assessed biochemical parameters for bone and mineral metabolism (Ca (Calcium), P (Phosphorus), ALP (Alkaline phosphatase) and additionally hsCRP (high sensitivity C-reactive protein) as cardiovascular inflammatory marker.
- To evaluate routinely checked parameters like albumin, hemoglobin and dialysis adequacy (KT/V).
- To collect and evaluate data from all adverse events in order to establish the safety profile of sVDRA(Selective Vitamin D Receptor Activator) in daily clinical practice.
- To collect mortality data 6 months after 12 months of observational period or 6 months after drop out.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 5 and receiving hemodialysis who is treated with sVDRA's (Selective Vitamin D Receptor Activator) injection
- •iPTH (intact parathyroid hormone) >300pg/ml, corrected serum Ca (Calcium) < 10.2 mg/dl, serum P (Phosphorus) < 6 mg/dl
- •Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients equal to or older than 18 years of age
- •Signed Informed consent by subject
- •Hypertensive and Diabetic subjects must be on an optimal and steady medication regimen for more than 30 days
排除标准
- •Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
- •Subject has participated in a clinical study within the last month
- •If sVDRA's (Selective Vitamin D Receptor Activator) are contraindicated according to the SmPC (Summary of Product Characteristics)
结局指标
主要结局
To assess percentage change in iPTH (intact Parathyroid Hormone) level monthly among hemodialysis patients with SHPT (Secondary Hyperparathyroidism) receiving sVDRA (Selective Vitamin D Receptor Activator) therapy
时间窗: 12 months
次要结局
- Calcium, Phosphorus, ALP (Alkaline Phosphatase)(After early termination)
- Albumin, hemoglobin and dialysis adequacy (KT/V)(After early termination)
- hsCRP (High Sensitivity C-Reactive Protein)(After early termination)
- Serious Adverse events(18 months)
- Mortality data(18 months)