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

Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.

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

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: Pitavastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 905
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 113-8421
    • Division of Nephrology, Department of Internal Medicine, Juntendo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pitavastatin; Pitavastatin in addition to optimal standard care	Drug: Pitavastatin; 1-4mg/day; Other Names: LIVALO
No Intervention: optimal standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	whole observational period
Myocardial infarction of the new onset	whole observational period

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarction of the new onset	whole observational period
Cardiac death	whole observational period

Other Outcome Measures

Outcome Measure	Time Frame
interventions for ischemic heart disease	whole observational period
Serious arrhythmia	whole observational period
Hospitalization for the heart failure	whole observational period
Hospitalization for the unstable angina	whole observational period
cerebral stroke	whole observational period
Bone fracture	whole observational period

Collaborators and Investigators

• Sponsor: Chieko Hamada
• Investigators: Principal Investigator: Yasuhiko Tomino, MD,PhD, Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): January 31, 2011
• Study Completion (Actual): September 30, 2014

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Mortality; Hemodialysis; Pitavastatin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pitavastatin
• Other Study ID Numbers: 208-032