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Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)

This study is currently recruiting participants.
Verified March 2009 by Juntendo University Hospital
Sponsor:
Information provided by:
Juntendo University Hospital
ClinicalTrials.gov Identifier:
NCT00846118
First received: February 17, 2009
Last updated: June 22, 2011
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.


Condition Intervention
Cardiovascular Disease
 Drug: Pitavastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Juntendo University Hospital:

Secondary Outcome Measures:
  • cardiac death, myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1550
Study Start Date: February 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pitavastatin
Pitavastatin in addition to optimal standard care
 Drug: Pitavastatin
1-4mg/day
Other Name: LIVALO
No Intervention: optimal standard care

Detailed Description:

It was already proved by the clinical trials that statins prevent from death and cardiovascular events. However, the efficacy of statins in patients with chronic hemodialysis has not been proved yet.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients under hemodialysis

  • patients with hypercholesterolemia as defined by any of following parameters:

    • LDL-C ≧ 100 mg / dL
    • TC ≧ 180 mg / dL
    • patients required cholesterol-lowering treatment by investigators.
  • patients aged 20-75 years
  • patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial

Exclusion Criteria:

  • patients taking statins or fibrates
  • patients enrolled to the other trials using contraindication drugs of pitavastatin
  • patients who had acute myocardial infarction within six months before the day of the agreement acquisition
  • patients scheduled PCI and CABG within six months after the day of the agreement acquisition
  • Patients who had diagnosis or doubt of malignant tumor
  • patients corresponded to "Contraindications" of pitavastatin
  • Familial hypercholesterolemia patients
  • patients judged ineligible by investigators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846118

Contacts
Contact: Yasuhiko Tomino, MD,PhD +81-35-802-1065 ext N.A. yasu@juntendo.ac.jp
Contact: Chieko Hamada, MD,PhD +81-35-802-1065 ext N.A. chieko@juntendo.ac.jp

Locations
Japan
Division of Nephrology, Department of Internal Medicine, Juntendo Hospital Recruiting
Tokyo, Japan, 113-8421
Contact: Yasuhiko Tomino, MD,PhD     +81-35-802-1065        
Contact: Chieko Hamada, MD,PhD     +81-35-802-1065        
Principal Investigator: Yasuhiko Tomino, MD,PhD            
Sponsors and Collaborators
Juntendo University Hospital
Investigators
Principal Investigator: Yasuhiko Tomino, MD,PhD Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Yasuhiko Tomino/Division of Nephrology, Department of Internal Medicine, Juntendo University School of Medicine, Juntendo University
ClinicalTrials.gov Identifier: NCT00846118     History of Changes
Other Study ID Numbers: 208-032
Study First Received: February 17, 2009
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Juntendo University Hospital:
Pitavastatin
Hemodialysis
Mortality
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 26, 2012