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The renal function trajectory in clinical trial design: challenges and opportunities.
Kidney International ( IF 14.8 ) Pub Date : 2024-10-01 , DOI: 10.1016/j.kint.2024.07.023 Steven Rosansky,Richard Glassock
Kidney International ( IF 14.8 ) Pub Date : 2024-10-01 , DOI: 10.1016/j.kint.2024.07.023 Steven Rosansky,Richard Glassock
The changes in renal function over time as surrogate endpoints for new drug trials are complicated by many factors, including the often-expected initial decrease in estimated glomerular filtration rate when a new drug is started. Two articles in the journal address this challenge, but multiple other challenges are explored in this commentary. To maximize the benefits of expensive new drugs that may slow decline in renal function, these drugs should be reserved for those patients who have a high probability of rapid loss of kidney function.
中文翻译:
临床试验设计中的肾功能轨迹:挑战与机遇。
作为新药试验替代终点的肾功能随时间的变化因许多因素而变得复杂,包括新药开始时通常预期的估计肾小球滤过率的初始下降。该杂志中的两篇文章解决了这一挑战,但本评论探讨了其他多个挑战。为了最大限度地发挥可减缓肾功能衰退的昂贵新药的益处,这些药物应保留给那些肾功能快速丧失可能性较高的患者。
更新日期:2024-09-23
中文翻译:
临床试验设计中的肾功能轨迹:挑战与机遇。
作为新药试验替代终点的肾功能随时间的变化因许多因素而变得复杂,包括新药开始时通常预期的估计肾小球滤过率的初始下降。该杂志中的两篇文章解决了这一挑战,但本评论探讨了其他多个挑战。为了最大限度地发挥可减缓肾功能衰退的昂贵新药的益处,这些药物应保留给那些肾功能快速丧失可能性较高的患者。