EUCTR2013-002610-13-DE进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
- •Male or female subject between 10 and 16 years of age, inclusive at the time of Screening
- •Subject is currently being 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 greater than or equal to 8.4 and less than or equal to 10.2 mg/dL
- •?A phosphorus value less than or equal to 6.5 mg/dL
- •?An intact parathyroid hormone value greater than 300 pg/mL and less than or equal to 2000 pg/mL
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 is expected to transfer to chronic 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
研究者
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