A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
3期
提前终止
NCT04064827
| 适应症 | Chronic Kidney Disease, Secondary Hyperparathyroidism |
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| 分期 | 3期 |
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| 申办方 | AbbVie |
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| 状态 | 提前终止 |
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| 受试者人数 | 2 人 |
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| 干预(药物) | Paricalcitol |
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| 开始日期 | 2020年9月16日 |
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| 完成日期 | 2025年6月9日 |
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| 结果公布日 | 2026年6月15日 |
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摘要
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).
Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Up to Week 12 · percentage of participants
| Participants Receiving Paricalcitol | 100 percentage of participants |
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Incidence of Hypercalcemia During Dosing Period 1
Up to Week 12 · Participants
| Participants Receiving Paricalcitol | 0 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。