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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Chieko Hamada, Juntendo University School of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846118
First Posted: February 18, 2009
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chieko Hamada, Juntendo University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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 Chieko Hamada, Juntendo University School of Medicine:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: whole observational period ]
  • Myocardial infarction of the new onset [ Time Frame: whole observational period ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: whole observational period ]
  • Myocardial infarction of the new onset [ Time Frame: whole observational period ]

Other Outcome Measures:
  • interventions for ischemic heart disease [ Time Frame: whole observational period ]
  • Serious arrhythmia [ Time Frame: whole observational period ]
  • Hospitalization for the heart failure [ Time Frame: whole observational period ]
  • Hospitalization for the unstable angina [ Time Frame: whole observational period ]
  • cerebral stroke [ Time Frame: whole observational period ]
  • Bone fracture [ Time Frame: whole observational period ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Chieko Hamada, Juntendo University School of Medicine:
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
Enzyme Inhibitors
Lipid Regulating Agents