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

Primary Purpose

Vascular Calcification, Atherosclerosis, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
atorvastatin
placebo
Sponsored by
Ercan OK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Calcification focused on measuring hemodialysis, endothelial function, coronary artery calcification, atherosclerosis, statin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Ege University School of Medicine, Division of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Statin

Placebo

Arm Description

Atorvastatin 40 mg/day

placebo

Outcomes

Primary Outcome Measures

progression of coronary artery calcification score
progression of carotid artery intima-media thickness
changes in the level of hsCRP

Secondary Outcome Measures

changes in the endothelial function
changes in the level of hsCRP

Full Information

First Posted
May 30, 2007
Last Updated
September 6, 2013
Sponsor
Ercan OK
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00481364
Brief Title
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
Official Title
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ercan OK
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Calcification, Atherosclerosis, Dyslipidemia, Inflammation
Keywords
hemodialysis, endothelial function, coronary artery calcification, atherosclerosis, statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statin
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
atorvastatin 40 mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 tb/day
Primary Outcome Measure Information:
Title
progression of coronary artery calcification score
Time Frame
one year
Title
progression of carotid artery intima-media thickness
Time Frame
one year
Title
changes in the level of hsCRP
Time Frame
one year
Secondary Outcome Measure Information:
Title
changes in the endothelial function
Time Frame
one year
Title
changes in the level of hsCRP
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercan Ok, MD
Organizational Affiliation
Ege University, Division of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University School of Medicine, Division of Nephrology
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

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

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