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

NCT ID: NCT00846118

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

905 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-01

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pitavastatin

Pitavastatin in addition to optimal standard care

Group Type ACTIVE_COMPARATOR

Pitavastatin

Intervention Type DRUG

1-4mg/day

optimal standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pitavastatin

1-4mg/day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LIVALO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chieko Hamada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chieko Hamada

Division of Nehprology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasuhiko Tomino, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Nephrology, Department of Internal Medicine, Juntendo Hospital

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

208-032

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anfibatide Phase Ib-IIa Clinical Trial
NCT01585259 COMPLETED PHASE1/PHASE2