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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009393
Receipt No. R000011033
Scientific Title Evaluation of the efficacy of atorvastatin in patients with CKD
Date of disclosure of the study information 2013/01/07
Last modified on 2015/03/03

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Basic information
Public title Evaluation of the efficacy of atorvastatin in patients with CKD
Acronym The efficacy of atorvastatin for CKD
Scientific Title Evaluation of the efficacy of atorvastatin in patients with CKD
Scientific Title:Acronym The efficacy of atorvastatin for CKD
Region
Japan

Condition
Condition CKD patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy of atorvastatin for maintenance of renal function in patients with CKD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Amount of urinary albumin
Key secondary outcomes 1.Lipid metabolism: LDL, HDL, TG, Apolipoprotein fractionation, MDA-LDL
2.High sensitive CRP
3.ADMA
4.Urinary L-FABP
5.Urinary 8-OHdG
6.ABI and CAVI
7.Carotid ultrasonography
8.Examination of the fundus

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients with CKD accompanied by hyperlipidemia (n=50) were administered 10mg of atorvastatin orally once a day. However, the maximum daily dose of atorvastatin is 40mg. The period of this study is 12 months after the administration of atorvastatin.
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are eligible if they are compatible with the following criteria.
1. CKD patients accompanied with hyperlipidemia. (administration of statin and /or ethyl icosapentate are not restricted)
2. Patients who agreed with the participation of the study based on informed consent before the study initiation, and filled in signature sealing or a signature and a date.
Key exclusion criteria Patients are excluded if they are compatible with any one of the following criteria.
1. Patients with a history of hypersensitivity for an ingredient of atorvastatin.
2. Patients whose liver function is thought to decrease; acute hepatitis, acute aggravation of the chronic hepatitis, cirrhosis, liver cancer, jaundice
3. A pregnant woman or the woman who may be pregnant and nursing mother.
4. Patients receiving telaprevir.
5. Patients with significant psychic disturbance or drug dependence disease or alcoholism.
6. Patients that going to hospital of all follow-up seems to be impossible.
7. Patients who are not able to understand a test instruction from medical experts of the client side or the doctors involved in the study.
8. Patients who judged as inadequate by the doctors involved in the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Suzuki
Organization Juntendo University Faculty of Medicine
Division name Department of Internal Medicine, Division of Nephrology
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-5802-1065
Email shitoshi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Suzuki
Organization Juntendo University Faculty of Medicine
Division name Department of Internal Medicine, Division of Nephrology
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL 03-5802-1065
Homepage URL
Email shitoshi@juntendo.ac.jp

Sponsor
Institute Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization None
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 順天堂大学付属順天堂医院
Juntendo University Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 07 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 Terminated
Date of protocol fixation
2012 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 07 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 25 Day
Last modified on
2015 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011033

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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