Differential Intervention Trial by Standard Therapy Versu... | NCT00846118

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

NCT00846118

Sponsor

Chieko Hamada

Status

Terminated

Last Update Posted

Aug 30, 2021Actual

Enrollment

905Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

Pitavastatin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2009Actual

Primary Completion Date

Jan 31, 2011Actual

Completion Date

Sep 30, 2014Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2021

Last Update Posted Date

Aug 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

905Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pitavastatin	Active Comparator	Pitavastatin in addition to optimal standard care	Drug: Pitavastatin
optimal standard care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pitavastatin	Drug	1-4mg/day	Pitavastatin	LIVALO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
interventions for ischemic heart disease		whole observational period
Serious arrhythmia		whole observational period
Hospitalization for the heart failure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasuhiko Tomino, MD,PhD	Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Nephrology, Department of Internal Medicine, Juntendo Hospital		Tokyo		113-8421	Japan