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

This study is currently recruiting participants.

Verified by Juntendo University Hospital, March 2009

First Received: February 17, 2009 Last Updated: March 24, 2009 History of Changes

Sponsored by:	Juntendo University Hospital
Information provided by:	Juntendo University Hospital
ClinicalTrials.gov Identifier:	NCT00846118

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

MedlinePlus related topics: Dialysis Heart Attack Kidney Failure

Drug Information available for: Pitavastatin NK 104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.

Further study details as provided by Juntendo University Hospital:

Primary Outcome Measures:

All cause death, Myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cardiac death, myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1550
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pitavastatin: Active Comparator Pitavastatin in addition to optimal standard care	Drug: Pitavastatin 1-4mg/day
optimal standard care: No Intervention

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 75 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

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

Contacts

Contact: Yasuhiko Tomino, MD,PhD	+81-35-802-1065 ext N.A.	yasu@juntendo.ac.jp
Contact: Chieko Hamada, MD,PhD	+81-35-802-1065 ext N.A.	chieko@juntendo.ac.jp

Locations

Japan
Division of Nephrology, Department of Internal Medicine, Juntendo Hospital	Recruiting
Tokyo, Japan, 113-8421
Contact: Yasuhiko Tomino, MD,PhD +81-35-802-1065
Contact: Chieko Hamada, MD,PhD +81-35-802-1065
Principal Investigator: Yasuhiko Tomino, MD,PhD

Sponsors and Collaborators

Juntendo University Hospital

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:	Juntendo University ( Yasuhiko Tomino/Division of Nephrology, Department of Internal Medicine, Juntendo University School of Medicine )
Study ID Numbers:	208-032
Study First Received:	February 17, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00846118 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Juntendo University Hospital:

Pitavastatin
Hemodialysis
Mortality
Cardiovascular disease

Study placed in the following topic categories:

NK 104

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
NK 104
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009