Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
研究概览
简要总结
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.
详细描述
Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 receiving dialysis. SHPT is an adaptive response to CKD and is characterized by an elevation in parathyroid hormone (PTH) and consecutively high calcium levels. Elevations in calcium levels, phosphate levels, and PTH are correlated with CKD disease progression as well as development or aggravation of cardiovascular impairment. Many CKD patients cannot be treated well with Vitamin D analogues because of effects on calcium. Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (paricalcitol IV).
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
- •Patients aged at least 18 years
- •Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL,
- •Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms:
- •cardiac disorder as cardiac arrhythmias
- •cardiac disorder signs and symptoms
- •cardiac neoplasm
- •cardiac valve disorder
- •heart failures
- •myocardial disorder
- •pericardial disorder
- •Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL
排除标准
- •Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics
- •Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.
结局指标
主要结局
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
时间窗: Baseline and Months 3, 6, 12, 18, and 24
Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).
次要结局
- Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements(Baseline to Month 24)
- Percentage of Participants With Hyperphosphatemia(Baseline and Months 3, 6, 12, 18, and 24)
- Percentage of Participants With Hypercalcemia(Baseline and Months 3, 6, 12, 18, and 24)
- Percentage of Participants With at Least a 30%-Reduction in iPTH Levels(Baseline and Months 3, 6, 12, 18, and 24)
- Number of Participants With Cardiac Disease Progression(Month 3, 6, 12, 18, and 24)
- Percentage of Participants Experiencing Hospitalization(24 months)
- Percentage of Participants With at Least One Concomitant Medication(24 months)