A Prospective, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules as Determined by Hypercalcemia in Pediatric Patients Ages 0 to 16 With Chronic Kidney Disease (CKD) Stage 5 Receiving Peritoneal Dialysis (PD) Within Current Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 18
- 主要终点
- Percentage of Participants With at Least One Incidence of Hypercalcemia
研究概览
简要总结
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).
详细描述
Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
- •The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
- •The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
- •Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
- •Patient has received paricalcitol or calcitriol for a minimum of 10 days.
排除标准
- •Patient is scheduled for a kidney transplant within 3 months.
- •Patient is expected to stop peritoneal dialysis within 3 months.
- •Patient is expected to transfer to hemodialysis within 3 months.
- •Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.
研究组 & 干预措施
Paricalcitol
Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
干预措施: Paricalcitol (Drug)
Calcitriol
Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
干预措施: Calcitriol (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Incidence of Hypercalcemia
时间窗: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs(Monitored from time of informed consent through end of study + 30 days (total of 745 days).)
- Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)(Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]))
- Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)(Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]))
- Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)(Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]))
- Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)(Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]))
- Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)(Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]))
- Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)(Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]))