Fassett Robert G, Geraghty Dominic P, Coombes Jeff S
The University of Queensland, Brisbane, QLD, Australia,
J Nephrol. 2014 Oct;27(5):515-9. doi: 10.1007/s40620-014-0058-z. Epub 2014 Feb 7.
Without a run-in phase, chronic kidney disease (CKD) patients enrolled in clinical trials may not be identified as having progressive disease. The aim of this analysis was to quantify the effects of a run-in phase on kidney function outcome in CKD patients enrolled in the Lipid Lowering and Onset of Renal Disease (LORD) trial.
The LORD trial assessed the effects of atorvastatin on the rate of change in the estimated glomerular filtration rate (eGFR) and included patients with serum creatinine 120 μmol/l. In this post hoc analysis, we assessed eGFR change during the 12-month period prior to enrolment, the 3-month run-in phase and the first 12-month period of the trial. Eighty of the original 132 patients (where retrospective data were available) were included. The rate of eGFR change during each period was compared.
Overall kidney function decreased during the 12 months prior to enrolment by (mean, SD) 0.39 ± 0.98 ml/min/1.73 m(2)/month, improved during the 3-month run-in phase by 0.48 ± 2.90 ml/min/1.73 m(2)/month and decreased during the first 12 months of the trial by 0.15 ± 0.57 ml/min/1.73 m(2)/month. However, only 39 % of patients had declining eGFR during the 12 months prior, 19 % in the 3-month run-in and 42 % during the first 12-month study phase.
Most patients (>60 %) entering this clinical trial had stable or improving kidney function. Enrolment was associated with further improved kidney function, which may have been due to 'regression to the mean' or to the Hawthorne effect. Investigators should include a run-in period to establish the presence of eGFR decline to use as an inclusion criterion in clinical trials assessing this measure of CKD progression.
在没有导入期的情况下，参与临床试验的慢性肾脏病（CKD）患者可能未被识别为患有进行性疾病。本分析的目的是量化导入期对参与脂质降低与肾病发生（LORD）试验的CKD患者肾功能结局的影响。
LORD试验评估了阿托伐他汀对估计肾小球滤过率（eGFR）变化率的影响，纳入了血清肌酐≤120μmol/l的患者。在这项事后分析中，我们评估了入组前12个月、3个月导入期和试验的前12个月期间的eGFR变化。纳入了原始132例患者中的80例（可获得回顾性数据）。比较了每个时期eGFR的变化率。
入组前12个月总体肾功能下降（均值，标准差）0.39±0.98 ml/min/1.73 m²/月，在3个月导入期改善了0.48±2.90 ml/min/1.73 m²/月，在试验的前12个月下降了0.15±0.57 ml/min/1.73 m²/月。然而，在入组前12个月中只有39%的患者eGFR下降，在3个月导入期为19%，在第一个12个月研究阶段为42%。
进入该临床试验的大多数患者（>60%）肾功能稳定或改善。入组与肾功能进一步改善相关，这可能是由于“均值回归”或霍桑效应。研究者应纳入一个导入期以确定eGFR下降的存在，作为评估CKD进展这一指标的临床试验的纳入标准。
