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| autoid | 22 |
| crg_id | CRG080500011 |
| titleoftrial | Effect of statin and fibrate on vascular function in chronic kidney disease |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Dogra |
| leadgivennames | Gursharan |
| leadposition | Renal Physician |
| leaddepartment | |
| leadorganisation | Sir Charles Gairdner Hospital |
| leadaddress | Hospital Avenue NEDLANDS Western Australia 6009 Australia |
| leademail | sdogra@iinet.net.au |
| leadphone | +61 8 9346 3333 |
| leadfax | +61 8 9346 2534 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | Pfizer CVL grants |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | 01/05/2002 |
| actualstart | 01/05/2002 |
| proposedcompletiondate | 06/2004 |
| actualcompletiondate | 11/2004 |
| multi_center_study | yes |
| numberofcentres | 2 |
| multi_national_study | no |
| countrycentres | Australia |
| researchquestion | Does lipid-modifying therapy lower risk for cardiovascular disease (CVD) in patients with chronic kidney disease (CKD)? |
| study_status_recruitment | Recruitment completed |
| study_status_recruitment_follow | Completed |
| healthcarecondition | Cardiovascualr disease in chronic kidney disease |
| intervention1 | Atorvastatin |
| intervention2 | Gemfibrozil |
| intervention3 | Placebo |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 17-75yo |
| totalrecruitment | 105 |
| inclusion | Inclusion criteria: All patients on haemodialysis or peritoneal dialysis for Chronic kidney disease, including patients with diabetes; Patients should be stable on dialysis for at least 6 months with adequate indices of dialysis (Fractional Reduction of Urea, FRU > 0.67 or Kt/V > 0.3); All patients with moderate-to-severe chronic kidney disease (GFR < 40ml/min), including patients with diabetes; Age range 18 ? 75 years, male and female. |
| exclusion | Exclusion Criteria: Nephrotic-range proteinuria; Active upper gastro-intestinal dyspepsia; Muscular disorders; Liver and muscle enzymes > 2 times upper limit of normal; Alcohol consumption > 3 standard drinks/day; Use of antioxidant vitamin supplements other than multivitamin B/folic acid preparations routinely used in haemodialysis patients; Immunosuppressive therapy for renal transplantation; Cardiovascular event or unstable cardiovascular disease in preceding 6 months; Drugs known to affect lipid-metabolism (eg. fish oil supplements); Significant psychiatric disorder; Active infection. |
| primaryoutcomes | 1. Post-ischaemic flow-mediated dilatation of the brachial artery. 2. Systemic arterial compliance (a measure of arterial elasticity) |
| secondaryoutcomes | 1. Post-glyceryl trinitrate brachial artery vasodilatation 2. Lipid and lipoprotein concentration 3. Apolipoprotein B, CIII and AI concentration 4. Markers of inflammation (CRP, IL-6), oxidative stress (plasma isoprostanes and dityrosine), nitric oxide bioavailability (cyclic guanosine monophosphate - cGMP), and thrombosis (fibrinogen, plasminogen activator inhibitor - PAI-1, e-selectin and vascular cell adhesion molecule - VCAM-1). |
| reference | Dogra G, Irish A, Chan D, Watts G. A randomized trial of the effect of statin and fibrate therapy on arterial function in CKD. American Journal of Kidney Diseases 2007; 49(6):776-785. [added by Gail Higgins 20/08/2007] |