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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chieko Hamada, Juntendo University School of Medicine
ClinicalTrials.gov Identifier:
NCT00846118
First received: February 17, 2009
Last updated: September 24, 2014
Last verified: September 2014
  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:


Further study details as provided by Juntendo University Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • Myocardial infarction of the new onset [ Time Frame: whole observational period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • Myocardial infarction of the new onset [ Time Frame: whole observational period ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • interventions for ischemic heart disease [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • Serious arrhythmia [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • Hospitalization for the heart failure [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • Hospitalization for the unstable angina [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • cerebral stroke [ Time Frame: whole observational period ] [ Designated as safety issue: No ]
  • Bone fracture [ Time Frame: whole observational period ] [ Designated as safety issue: No ]

Estimated Enrollment: 1550
Study Start Date: February 2009
Estimated Study Completion Date: March 2015
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846118

Locations
Japan
Division of Nephrology, Department of Internal Medicine, Juntendo Hospital
Tokyo, Japan, 113-8421
Sponsors and Collaborators
Chieko Hamada
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: Chieko Hamada, Division of Nehprology, Juntendo University School of Medicine
ClinicalTrials.gov Identifier: NCT00846118     History of Changes
Other Study ID Numbers: 208-032
Study First Received: February 17, 2009
Last Updated: September 24, 2014
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
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014