A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 237
- 试验地点
- 19
- 主要终点
- Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
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 Zemplar 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 Greece.
详细描述
The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.
The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.
A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:
- 40% reduction in the base iPTH level is achieved, and/or;
- serum iParathormone level < 300 pg/mL.
Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.
研究设计
- 研究类型
- Observational
- 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
- •Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
- •Subject is receiving chronic hemodialysis.
- •Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
- •Subject has provided their informed consent to participate.
排除标准
- •Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^
- •Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
- •Subject has participated in clinical study within the last month.
- •Zemplar is contraindicated according to the Summary of Product Characteristics.
结局指标
主要结局
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations
时间窗: Baseline to Month 24 Visit
The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized
时间窗: Baseline to Month 24 Visit
The mean (average) number of days hospitalized per participant for those hospitalized during the study.
次要结局
- The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)(Baseline to Month 24 Visit)
- The Incidence of Clinically Significant Hypercalcemia(Baseline to Month 24 Visit)
- The Incidence of Clinically Significant Hyperphosphatemia(Baseline to Month 24 Visit)
- The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product(Baseline to Month 24 Visit)
- To Estimate the Incidence of (S)AEs/(S)ADRs(Baseline to Month 24 Visit)