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Improving Patient Selection in Clinical Trials: Should We Start Using the Pretrial eGFR Decline as Risk Enrichment Criterion?

作者信息

Jongs Niels, Heerspink Hiddo J L

机构信息

Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

Clin J Am Soc Nephrol. 2025 Jan 1;20(1):6-8. doi: 10.2215/CJN.0000000630. Epub 2024 Dec 12.

DOI:10.2215/CJN.0000000630
PMID:39666391
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11737441/
Abstract
摘要

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本文引用的文献

1
Albuminuria and Rapid Kidney Function Decline as Selection Criteria for Kidney Clinical Trials in Type 1 Diabetes Mellitus.白蛋白尿和肾功能快速下降作为1型糖尿病肾脏临床试验的入选标准。
Clin J Am Soc Nephrol. 2025 Jan 1;20(1):62-71. doi: 10.2215/CJN.0000000000000567. Epub 2024 Nov 18.
2
A randomized, open-label, clinical trial examined the effects of canagliflozin on albuminuria and eGFR decline using an individual pre-intervention eGFR slope.一项随机、开放标签、临床试验使用个体干预前 eGFR 斜率来研究卡格列净对白蛋白尿和 eGFR 下降的影响。
Kidney Int. 2024 Nov;106(5):972-984. doi: 10.1016/j.kint.2024.08.019. Epub 2024 Aug 30.
3
Large Between-Patient Variability in eGFR Decline before Clinical Trial Enrollment and Impact on Atrasentan's Efficacy: A Analysis from the SONAR Trial.临床试验入组前估算肾小球滤过率（eGFR）下降的患者间差异较大及其对阿曲生坦疗效的影响：来自SONAR试验的分析
J Am Soc Nephrol. 2021 Nov;32(11):2731-2734. doi: 10.1681/ASN.2021040498. Epub 2021 Aug 20.
4
Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.非奈利酮对 2 型糖尿病患者慢性肾脏病结局的影响。
N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.
5
Dapagliflozin in Patients with Chronic Kidney Disease.达格列净治疗慢性肾脏病患者。
N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
6
Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial.阿曲生坦与伴有慢性肾脏疾病的 2 型糖尿病患者的肾脏事件（SONAR）：一项双盲、随机、安慰剂对照试验。
Lancet. 2019 May 11;393(10184):1937-1947. doi: 10.1016/S0140-6736(19)30772-X. Epub 2019 Apr 14.
7
Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy.卡格列净与 2 型糖尿病和肾病患者的肾脏结局。
N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.