NCT01382212已完成3 期
A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
AbbVie (prior sponsor, Abbott)0 个研究点目标入组 13 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Percentage of Subjects With Hypercalcemia
研究概览
简要总结
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
- •Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
- •For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:
- •A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
- •A phosphorus value ≤ 6.5 mg/dL
- •An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL
排除标准
- •Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
- •Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
- •Subject has had a parathyroidectomy within 12 weeks prior to Screening
- •Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
- •Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
- •Subject is receiving cinacalcet at the time of Screening
研究组 & 干预措施
Paricalcitol
Experimental
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
干预措施: paricalcitol (Drug)
结局指标
主要结局
Percentage of Subjects With Hypercalcemia
时间窗: Day 1 to Week 12
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \> 10.2 mg/dL (2.55 mmol/L).
次要结局
- Red Blood Cells: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Osteocalcin: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings(Baseline (Day 1) to Final Visit (up to Week 12))
- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Oral Body Temperature: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL(Baseline (last measurement collected prior to the first dose) to Week 12)
- Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline(Baseline (last measurement collected prior to the first dose) to Week 12)
- Hemoglobin: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Hematocrit: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Total Protein and Albumin: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Number of Subjects With Potentially Clinically Significant Physical Examination Findings(Baseline (Day 1) and Final Visit (up to Week 12))
- Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Number of Subjects With Adverse Events(From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).)
- Alkaline Phosphatase: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
- Heart Rate: Mean Change From Baseline to Final Visit(Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12))
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