Overview

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

Status:
Terminated
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VU University Medical Center
Collaborators:
Bristol-Myers Squibb
Medical Research Foundation, The Netherlands
Treatments:
alpha-Tocopherol
Pravastatin
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Criteria
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