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CompletedNCT00481364Updated Sep 9, 2013

Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients

A Phase 3 interventional study of atorvastatin and placebo in Vascular Calcification, Atherosclerosis and Dyslipidemia, sponsored by Ercan OK. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-09-09.

Sponsored by Ercan OK · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
446
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation.

Read the detailed description

The effects of statin treatment on coronary artery calcifications, carotid artery intima-media thickness, and endothelial functions have never been investigated in hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are derived from small studies with short follow-up.

We postulate that atorvastatin would reduce progression of coronary calcification and carotid artery intima-media thickness, decrease inflammation, and improve endothelial function.

In this prospective, controlled, randomized study, four hundred forty-six prevalent hemodialysis patients who meet inclusion and exclusion criteria will be randomized to atorvastatin (20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms (each arm consists of 223 patients), after completion of baseline investigations. Randomization will be performed with random permuted blocks and will be stratified according to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use, and dialysate calcium level. Follow-up period will be twelve months.

It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate of 5%, of detecting a significant difference between treatment arms. Dropout rate is expected to be 20%, not to be replaced.

02

Conditions studied

  • Vascular Calcification
  • Atherosclerosis
  • Dyslipidemia
  • Inflammation

Keywords

  • hemodialysis
  • endothelial function
  • coronary artery calcification
  • atherosclerosis
  • statin
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 446 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Ercan OK is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged between 18 and 80 years
  • on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
  • willingness to participate to the study with a written informed consent

Exclusion criteria

Exclusion Criteria:

  • to have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
  • to be scheduled for living donor renal transplantation
  • pregnancy or lactating
  • history of coronary bypass grafting, acute myocardial infarction or unstable angina pectoris confirmed by angiography within three months of randomization
  • presence of an absolute indication to use lipid lowering drug or an absolute contraindication for lipid lowering therapy according to investigator's opinion
  • history of statin sensitivity or adverse reaction to statins
  • receiving any lipid-lowering agents within three months of randomization
  • uncontrolled hypothyroidism defined as TSH level higher than 1.5 times of upper limit
  • receipt of any investigational drug within 30 days before randomization
  • inability to tolerate oral medication or history of significant malabsorption
  • treatment with steroids or immunosuppressive drugs
  • alcohol abuse, drug abuse
  • ALT and/or AST levels more than three times above the upper limit of normal or symptomatic hepatobiliary disease
  • unexplained CK > 3 times the upper limit of the normal range
  • inability to give informed consent because of mental incompetence or a psychiatric disorder
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
446 participants (actual)

Study arms

  • Active comparator
    Statin

    Atorvastatin 40 mg/day

    Drug: atorvastatin

  • Placebo comparator
    Placebo

    placebo

    Drug: placebo

Interventions

  • Drugatorvastatin

    atorvastatin 40 mg/day

  • Drugplacebo

    1 tb/day

06

What researchers measure

Primary outcomes

  1. progression of coronary artery calcification score

    Time frame: one year

  2. progression of carotid artery intima-media thickness

    Time frame: one year

  3. changes in the level of hsCRP

    Time frame: one year

Secondary outcomes

  1. changes in the endothelial function

    Time frame: one year

  2. changes in the level of hsCRP

    Time frame: one year

07

Study locations

1 site
  • Ege University School of Medicine, Division of Nephrology
    Bornova, Izmir 35100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00481364
Lead sponsor
Ercan OK
Collaborators
Pfizer
Responsible party
Ercan OK (professor, Ege University) — Sponsor-investigator
First posted
Jun 1, 2007
Start date
Nov 2006
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Sep 9, 2013

Study contacts

Ercan Ok, MD
principal investigator · Ege University, Division of Nephrology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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