Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
研究概览
简要总结
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
详细描述
Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.
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
- •Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
- •≥ 18 years of age,
- •Willing to sign the patient information and informed consent form,
- •Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
- •between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
- •higher than 800 pg/mL and parathyroidectomy is contraindicated.
- •The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.
排除标准
- •Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
- •The patient is already treated with Zemplar (paricalcitol injection),
- •Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
- •Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
结局指标
主要结局
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
时间窗: 6 months
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
次要结局
- Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy(6 months prior to start of study through baseline)
- Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment(6 months)
- Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism(6 months prior to start of study through 6 months of treatment)
- Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6(6 months)
- Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance(6 months prior to start of study through 6 months of treatment)
- Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment(6 months)
- Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance(6 months prior to start of study through 6 months of treatment)
- Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy(6 months prior to start of study through baseline)