UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001778 |
|---|---|
| Receipt number | 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 14:24:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
asucatrial@mail2.adm.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
