BENITIONSClinical Trial Intelligence

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
分期3期
申办方Sanofi
状态提前终止
受试者人数21 人
干预(药物)Doxercalciferol (GZ427397), Calcitriol
开始日期2017年1月19日
完成日期2025年6月11日
结果公布日2026年7月2日

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
Calcitriol (Rocaltrol®)71.4 percentage of participants
Perecntage difference-52.9 (95% CI -99.90–-5.98)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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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。