The impact of pre-intervention rate of kidney function change on the assessment of CKD progression

Fassett, Robert G., Geraghty, Dominic P. and Coombes, Jeff S. (2014) The impact of pre-intervention rate of kidney function change on the assessment of CKD progression. Journal of Nephrology, 27 5: 515-519. doi:10.1007/s40620-014-0058-z

Author Fassett, Robert G.
Geraghty, Dominic P.
Coombes, Jeff S.
Title The impact of pre-intervention rate of kidney function change on the assessment of CKD progression
Journal name Journal of Nephrology   Check publisher's open access policy
ISSN 1121-8428
Publication date 2014-10-01
Year available 2014
Sub-type Article (original research)
DOI 10.1007/s40620-014-0058-z
Open Access Status Not Open Access
Volume 27
Issue 5
Start page 515
End page 519
Total pages 5
Place of publication Heidelberg, Germany
Publisher Springer
Language eng
Formatted abstract
Background 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.
Methods 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.
Results Overall kidney function decreased during the 12 months prior to enrolment by (mean, SD) 0.39 ± 0.98 ml/min/1.73 m2/month, improved during the 3-month run-in phase by 0.48 ± 2.90 ml/min/1.73 m2/month and decreased during the first 12 months of the trial by 0.15 ± 0.57 ml/min/1.73 m2/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.
Conclusion 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.

Keyword Statins
Chronic kidney disease
Glomerular filtration rate
Hawthorne effect
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Human Movement and Nutrition Sciences Publications
School of Medicine Publications
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Created: Wed, 29 Oct 2014, 23:28:10 EST by Sandrine Ducrot on behalf of School of Human Movement and Nutrition Sciences