UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009393 |
|---|---|
| Receipt number | 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 22:46:57 |
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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
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
shitoshi@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011033
