- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384618
Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study
Effect of an Oxidative-Stress-Reducing Strategy Consisting of Pravastatin, Vitamin E and Homocysteine-Lowering on Carotid Intima-Media Thickness in Patients With Mild-to-Moderate Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Patients with mild-to-moderate renal failure have an increased risk of cardiovascular disease (CVD), which is not fully explained by the presence of classical cardiovascular risk factors. Oxidative stress has been proposed to play a major role in the development of CVD among renal failure patients. We investigated, in patients with mild-to-moderate chronic kidney disease (CKD), the effect of an oxidative-stress-lowering therapy with pravastatin, vitamin E and homocysteine-lowering on carotid intima-media thickness and endothelial function (two strong surrogate markers of cardiovascular risk), and renal function.
Methods: 93 patients with CKD (Cockcroft-Gault equation; mean: 41±17 ml / min per 1.73 m2) who were free of manifest arterial occlusive disease and diabetes mellitus were included in the Anti-oxidant Therapy In Chronic renal insufficiency (ATIC) study, a randomized, double-blind, placebo-controlled trial. The active treatment group received pravastatin 40 mg/day to which after 6 months vitamin E 300 mg/day was added and after another 6 months homocysteine-lowering therapy (folic acid 5 mg/day, pyridoxine 100 mg, vitamin B-12 1 mg/day). The placebo group received matching placebos at onset, and 6 and 12 months later. Blood pressure in both groups was managed according to a standard protocol to achieve a blood pressure of < 140/90 mmHg. Patients were followed up for two years. Measurements of common carotid artery intima-media thickness (CCA-IMT) and brachial artery endothelium-dependent, flow-mediated dilatation (BA-FMD) were performed at randomisation and after 6, 12 and 18 months. Plasma oxidized LDL (oxLDL) and plasma malondialdehyde (MDA) were measured as markers of oxidative stress at randomisation and after 6, 12, 18 and 24 months. We used generalized estimating equations (GEE) for data analysis.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Holland
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Amsterdam, North Holland, Netherlands, 1007 MB
- VU University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:chronic
- kidney disease (clearence between 15-70ml/min)
Exclusion Criteria:
- diabetes mellitus (ADA criteria), active vasculitis, nephrotic syndrome (>3g protein/24h urine), renal transplantation, fasting total cholesterol > 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion or known ischaemic coronary, cerebrovascular or peripheral arterial disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Common carotid artery intima media thickness
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Brachial artery flow mediated vasodilatation
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Secondary Outcome Measures
Outcome Measure |
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Renal function
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Prof. Peter M ter Wee, MD, PhD, Depratment of Nephrology, VU University Medical Center
Publications and helpful links
General Publications
- Nanayakkara PW, Teerlink T, Stehouwer CD, Allajar D, Spijkerman A, Schalkwijk C, ter Wee PM, van Guldener C. Plasma asymmetric dimethylarginine (ADMA) concentration is independently associated with carotid intima-media thickness and plasma soluble vascular cell adhesion molecule-1 (sVCAM-1) concentration in patients with mild-to-moderate renal failure. Kidney Int. 2005 Nov;68(5):2230-6. doi: 10.1111/j.1523-1755.2005.00680.x.
- Nanayakkara PW, Kiefte-de Jong JC, ter Wee PM, Stehouwer CD, van Ittersum FJ, Olthof MR, Teerlink T, Twisk JW, van Guldener C, Smulders YM. Randomized placebo-controlled trial assessing a treatment strategy consisting of pravastatin, vitamin E, and homocysteine lowering on plasma asymmetric dimethylarginine concentration in mild to moderate CKD. Am J Kidney Dis. 2009 Jan;53(1):41-50. doi: 10.1053/j.ajkd.2008.06.016. Epub 2008 Sep 11.
- Nanayakkara PW, van Guldener C, ter Wee PM, Scheffer PG, van Ittersum FJ, Twisk JW, Teerlink T, van Dorp W, Stehouwer CD. Effect of a treatment strategy consisting of pravastatin, vitamin E, and homocysteine lowering on carotid intima-media thickness, endothelial function, and renal function in patients with mild to moderate chronic kidney disease: results from the Anti-Oxidant Therapy in Chronic Renal Insufficiency (ATIC) Study. Arch Intern Med. 2007 Jun 25;167(12):1262-70. doi: 10.1001/archinte.167.12.1262.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Protective Agents
- Micronutrients
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Vitamins
- Antioxidants
- Vitamin E
- Pravastatin
Other Study ID Numbers
- C97-1707
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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