drugset / Trial / NCT00384618

Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study

NCT00384618

RandomizedParallel-groupDouble-blindTreatment

Summary

The ATIC study is a randomised, double- blind, placebo-controlled trial in which the effects of oxidative stress-lowering treatment on vascular function and structure are studied in patients with chronic non-diabetic renal failure who are free from manifest arterial occlusive disease. Participants in the trial were randomised to active treatment consisting of add-on therapy with pravastatin, vitamin E and homocysteine-lowering therapy, or to placebo. Subjects not using angiotensin converting enzyme inhibitors (ACE-inhibitors) or angiotensin receptor blockers (ARBs) at inclusion were put on ACE-inhibitors for at least two weeks before the baseline measurement and randomisation. Those who were on ARBs continued their ARBs. We excluded individuals with diabetes mellitus (ADA criteria), active vasculitis, nephrotic syndrome (\>3gr/24hr urine protein), renal transplantation, fasting total cholesterol \> 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion or known ischemic cardiac, cerebrovascular or peripheral arterial disease. Ninety-three patients (out of 118 eligible patients) took part in the study and written informed consent was obtained from all participants.

Timeline

Start
2001-05
Primary completion
Completion
2005-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Pravastatin Small molecule 40 mg
Subject Vitamin E Other / unclassified 300 mg