Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)
1 other identifier
interventional
905
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2014
CompletedAugust 30, 2021
August 1, 2021
2 years
February 17, 2009
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
all cause mortality
whole observational period
Myocardial infarction of the new onset
whole observational period
Secondary Outcomes (2)
Cardiac death
whole observational period
Myocardial infarction of the new onset
whole observational period
Other Outcomes (6)
interventions for ischemic heart disease
whole observational period
Serious arrhythmia
whole observational period
Hospitalization for the heart failure
whole observational period
- +3 more other outcomes
Study Arms (2)
Pitavastatin
ACTIVE COMPARATORPitavastatin in addition to optimal standard care
optimal standard care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chieko Hamadalead
Study Sites (1)
Division of Nephrology, Department of Internal Medicine, Juntendo Hospital
Tokyo, 113-8421, Japan
MeSH Terms
Conditions
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Yasuhiko Tomino, MD,PhD
Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Division of Nehprology
Study Record Dates
First Submitted
February 17, 2009
First Posted
February 18, 2009
Study Start
February 1, 2009
Primary Completion
January 31, 2011
Study Completion
September 30, 2014
Last Updated
August 30, 2021
Record last verified: 2021-08