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)
Фаза 3
Прекращено
NCT04064827
| Заболевание | Chronic Kidney Disease, Secondary Hyperparathyroidism |
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| Фаза | Фаза 3 |
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| Спонсор | AbbVie |
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| Статус | Прекращено |
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| Участники | 2 участн. |
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| Вмешательство | Paricalcitol |
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| Дата начала | 16.09.2020 |
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| Дата завершения | 9.06.2025 |
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| Публикация результатов | 15.06.2026 |
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Кратко
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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