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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001778
Receipt No. R000002130
Scientific Title Assessment of clinical usefulness in CKD patients with atorvastatin trial (ASUCA Trial)
Date of disclosure of the study information 2009/03/17
Last modified on 2014/01/07

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Basic information
Public title Assessment of clinical usefulness in CKD patients with atorvastatin trial (ASUCA Trial)
Acronym ASUCA Trial
Scientific Title Assessment of clinical usefulness in CKD patients with atorvastatin trial (ASUCA Trial)
Scientific Title:Acronym ASUCA Trial
Region
Japan

Condition
Condition Hyperlipidemia with Chronic Kidney Disease (CKD)
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of atorvastatin on kidney function measured by estimated glomerular filtration rate (eGFR) in patients with hyperlipidemia with CKD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in eGFR
Key secondary outcomes 1) change in LDL-cholesterol, 2) change in triglyceride, 3) change in urinary albumin (mg/g*Cr), 4) cardiovascular event, 6) all-cause death, 8) safety parameters

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Patients are given atorvastatin 10 mg/day under dietary therapy based on the "Clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease" and "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases". The dosage of atorvastatin can be increased up to 20mg/day when atorvastatin 10 mg/day fails to achieve the LDL-cholesterol target (less than 100mg/dL). When the target is not achieved with atorvastatin 20mg/day, antihyperlipidemic drugs except the other statins and fibrates can be added.
Interventions/Control_2 Patients are treated with dietary therapy alone based on the "Clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease" and "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases". Antihyperlipidemic durugs except statins can be administered when dietary therapy alone fails to achieve the LDL-cholesterol target (less than 100mg/dL) after three months. When patients have already been treated with antihyperlipidemic drugs except statins at enrollment, the drugs can be continued.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) written informed consent, 2) age: from 40 to 74 years old, 3) either positive urine protein test or eGFR less than 60 ml/min/1.73m2 three months before enrollment, 4) eGFR less than 60 ml/min/1.73m2 at enrollment, 5) LDL-cholesterol of 140mg/dL or greater (LDL-cholesterol of 100mg/dL or greater if patients have already received an antihyperlipidemic drugs), 6) patient who are not treated with statins
Key exclusion criteria 1) hepatic disease with decreased liver function, 2) familial hypercholesterolaemia, 3) eGFR less than 30 ml/min/1.73m2, 4) uncontrolled hypertension (systolic blood pressure of 180 mmHg or greater or diastolic blood pressure of 110 mmHg or greater), 5) poor controlled diabetics (HbA1c of 8.5% or greater), 6) nephrotic syndrome, 7) pregnancy or breast feeding, 8) known intolerance/adverse effects to atorvastatin, 9) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuwa Nakao
Organization Kyoto University Graduate School of Medicine
Division name Department of Medicine and Clinical Science
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3168
Email asucatrial@mail2.adm.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Department of EBM Research
Organization Kyoto University Hospital
Division name iACT
Zip code
Address Syogoinkawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 0120-105894
Homepage URL http://plaza.umin.ac.jp/~kdaiebm/project/asuca.html
Email asucatrial@mail2.adm.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department account fund
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 05 Month 31 Day
Date of closure to data entry
2013 Year 06 Month 28 Day
Date trial data considered complete
2013 Year 08 Month 09 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 16 Day
Last modified on
2014 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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