NCT00481364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
446

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

May 30, 2007

Last Update Submit

September 6, 2013

Conditions

Vascular CalcificationAtherosclerosisDyslipidemiaInflammation

Keywords

hemodialysisendothelial functioncoronary artery calcificationatherosclerosisstatin

Outcome Measures

Primary Outcomes (3)

  • progression of coronary artery calcification score

    one year

  • progression of carotid artery intima-media thickness

    one year

  • changes in the level of hsCRP

    one year

Secondary Outcomes (2)

  • changes in the endothelial function

    one year

  • changes in the level of hsCRP

    one year

Study Arms (2)

Statin

ACTIVE COMPARATOR

Atorvastatin 40 mg/day

Drug: atorvastatin

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

atorvastatinDRUG

atorvastatin 40 mg/day

Statin
placeboDRUG

1 tb/day

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University School of Medicine, Division of Nephrology

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vascular CalcificationAtherosclerosisDyslipidemiasInflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ercan Ok, MD

    Ege University, Division of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations

TU(1)