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Updated: Jun 21, 2025
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Assessment of Kidney Function in Mouse Models of Glomerular Disease
Published on: June 30, 2018
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临床试验设计,以评估治疗对膜过率下降的治疗效应
Hiddo J L Heerspink1, Dustin J Little2, Lars Frison3
1Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; The George Institute for Global Health, Sydney, Australia.
Kidney international
|July 5, 2024
概括
新的试验设计,包括洗和活跃的随机抽取,通过排除急性药物影响,准确地测量长期病进展. 这些方法为评估缓慢膜过率下降的治疗提供了更好的统计能力.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 临床试验设计 临床试验设计
- 药理学 药理学是指药理学的学科.
背景情况:
- 淋巴膜过率 (GFR) 的下降是慢性病 (CKD) 进展和衰竭的关键指标.
- 对CKD进展的干预可以导致急性GFR减少,使长期益处的评估变得复杂.
- 标准的随机试验设计可能无法有效地将干预的慢性影响与GFR的急性变化隔离起来.
研究的目的:
- 评估洗和主动运行随机撤回试验设计在评估长期GFR下降的实用性.
- 确定这些替代设计是否能够有效地将急性GFR效应的影响排除在治疗评估之外.
- 将这些设计的统计能力与测量GFR下降的标准随机试验设计进行比较.
主要方法:
- 分别使用empagliflozin和atrazent的两项临床试验 (EMPA-REG结果和SONAR) 的后期分析.
- 使用标准慢性斜率方法计算的GFR下降的比较,与使用冲洗或活跃运行周期的方法进行比较.
- 使用线性混合模型和单斜率模型来估计从随机化到洗结束或从治疗特定基线GFR值的GFR变化.
主要成果:
- 在EMPA-REG Outcome中,冲洗设计显示GFR斜率效应为1.72 mL/min/1.73 m2/year,类似于使用冲洗期观察到的1.64 mL/min/1.73 m2/year.
- 在SONAR中,主动运行随机撤回设计显示了0.72 mL/min/1.73 m2/year的GFR斜率效应,与从治疗特定基线估计的0.77 mL/min/1.73 m2/year相当.
- 两种替代试验设计都表现出优越的统计能力,与评估GFR下降的标准随机设计相比.
结论:
- 冲洗和主动运行随机抽取设计是准确计算治疗对GFR降低CKD的影响的有效模型.
- 这些设计成功地减轻了急性GFR变化的混影响,提供了对长期治疗益处的更清晰评估.
- 这些发现支持在未来的临床试验中采用这些替代试验设计来研究CKD进展.
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