Study protocol

The Lipid lowering and Onset of Renal Disease (LORD) Trial: A randomized double blind placebo controlled trial assessing the effect of atorvastatin on the progression of kidney disease

Robert G Fassett¹ , Madeleine J Ball² , Iain K Robertson² , Dominic P Geraghty² and Jeff S Coombes³

¹Renal Research Tasmania, Launceston General Hospital, Charles St., Launceston, Tasmania, 7005, Australia

²School of Human Life Sciences, University of Tasmania, Launceston, Tasmania, 7250, Australia

³School of Human Movement Studies, University of Queensland, St. Lucia, Queensland, 4072, Australia

author email corresponding author email

BMC Nephrology 2008, 9:4doi:10.1186/1471-2369-9-4

Published:	18 March 2008

Abstract

Background

There is evidence that dyslipidemia is associated with chronic kidney disease (CKD). Experimental studies have established that lipids are damaging to the kidney and animal intervention studies show statins attenuate this damage. Small clinical trials, meta-analyses, observational studies and post-hoc analyses of cardiovascular intervention studies all support the concept that statins can reduce kidney damage in humans. Based on this background, a double blind randomized placebo controlled trial was designed to assess the effectiveness of atorvastatin 10 mg on slowing the progression of kidney disease in a population of patients with CKD.

Method/Design

The Lipid lowering and Onset of Renal Disease (LORD) trial is a three-year, single center, multi-site, double blind, randomized, placebo controlled trial. The primary outcome measure is kidney function measured by eGFR calculated by both Modification of Diet in Renal Disease (MDRD) and Cockcroft and Gault equations. Secondary outcome measures include kidney function measured by 24-hour urine creatinine clearance and also 24-hour urinary protein excretion, markers of oxidative stress, inflammation and drug safety and tolerability.

Discussion

The results of this study will help determine the effectiveness and safety of atorvastatin and establish its effects on oxidative stress and inflammation in patients with CKD.

Trial Registration

ANZCTRN012605000693628