Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 24
- 主要终点
- Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population
研究概览
简要总结
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
详细描述
This was a single arm, open, multicenter, non-interventional, post marketing observational study, which has been conducted in 24 sites in Greece, under normal clinical practice and as per the locally approved Summary of Product Characteristics (SmPC) of study medication (oral paricalcitol). Eligible patients were followed up for a 12-month period after enrollment. All study activities were consistent with European Union (EU) directive 2001/20/EC section for non-interventional studies.
In this study, paricalcitol was prescribed on an on-label basis in an everyday setting to observe drug actions in a distinct geography (Greece with > 250 days/year of sunny days) as well as in a significant subpopulation (Chronic Kidney Disease [CKD] stages 3-5 transplanted patients). Dose tolerability, treatment effects, as well as maintenance of results were registered for a 12-month period in order to obtain experience in the long term use of paricalcitol capsules. Furthermore, in centers where additional blood parameters were examined as part of clinical routine, these were recorded and analyzed.
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
- 是
入选标准
- •Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment
- •Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients > 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
- •Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II)
- •Parathormone value of > 1000 pg/mL (sign of tertiary hyperparathyroidism)
- •Treatment with Vitamin D within the last 1 month prior to inclusion into the study
结局指标
主要结局
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population
时间窗: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants
时间窗: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.
次要结局
- Change From Baseline in Urea Levels at Months 6 and 12(Baseline, Month 6, Month 12)
- Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels(Measured from start of study, up to a maximum of 12 months)
- Mean Duration of Effect Sustainability (Months)(Measured from start of study, up to a maximum of 12 months)
- Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range(Enrollment Visit, Month 3, Month 6, Month 9, Month 12)
- Number of Participants With Serum Calcium Level Abnormalities(Baseline, Enrollment Visit, Month 6, Month 12)
- Number of Participants With Serum Phosphorus Level Abnormalities(Baseline, Enrollment Visit, Month 6, Month 12)
- Change in Dipstick Albuminuria Grade From Baseline to Month 6(Baseline, Month 6)
- Change in Dipstick Albuminuria Grade From Baseline to Month 12(Baseline, Month 12)
- Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study(Baseline, Enrollment Visit, Month 6, Month 12)
- Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)(From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.)
- Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study(Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12)
- Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study(Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12)
- Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12(Baseline, Month 6, Month 12)
- Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12(Baseline, Month 6, Month 12)
- Change From Baseline in Creatinine Levels at Months 6 and 12(Baseline, Month 6, Month 12)
- Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12(Baseline, Month 6, Month 12)
- Change From Enrollment in Total Cholesterol Levels at Months 6 and 12(Enrollment, Month 6, Month 12)
- Change From Enrollment in Triglyceride Levels at Months 6 and 12(Enrollment, Month 6, Month 12)
- Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12(Enrollment, Month 6, Month 12)
- Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12(Enrollment, Month 6, Month 12)
- Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12(Baseline, Month 6, Month 12)
- Homocysteine Values Throughout the Study(Baseline, Enrollment Visit, Month 6, Month 12)