Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
3期
提前终止
NCT02859896
| 适应症 | Secondary Hyperparathyroidism-Chronic Kidney Disease |
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| 分期 | 3期 |
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| 申办方 | Sanofi |
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| 状态 | 提前终止 |
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| 受试者人数 | 21 人 |
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| 干预(药物) | Doxercalciferol (GZ427397), Calcitriol |
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| 开始日期 | 2017年1月19日 |
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| 完成日期 | 2025年6月11日 |
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| 结果公布日 | 2026年7月2日 |
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摘要
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12
Baseline (Day 1) up to Week 12 · percentage of participants
| Doxercalciferol (Hectorol®) | 14.3 percentage of participants |
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| Calcitriol (Rocaltrol®) | 71.4 percentage of participants |
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| Perecntage difference | -52.9 (95% CI -99.90–-5.98) |
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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。