UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012838 |
|---|---|
| Receipt number | R000014997 |
| Scientific Title | AST-120 for functional abnormalities of HDL in patients with CKD |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2019/01/29 21:48:14 |
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Basic information
Public title
AST-120 for functional abnormalities of HDL in patients with CKD
Acronym
CKD-HDL and AST-120
Scientific Title
AST-120 for functional abnormalities of HDL in patients with CKD
Scientific Title:Acronym
CKD-HDL and AST-120
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic kidney disease (CKD) is one of strongest risk factors of cardiovascular disease (CVD). CVD is induced by abnormal functions of macrophage and lipoproteins in atherosclerotic lesions. Oral activated charcoal, ASST-120 is known to have beneficial effect for CKD-induced acceleration of atherosclerosis. The aim of this study is to examine whether AST-120 modulates HDL functions in patients with CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HDL functions to macrophages, such as inflammatory response and lipid handling.
Change of proteins or uremic toxins in HDL molecules.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment using AST-120 for 6 months in patients with CKD stage4 or 5.
Interventions/Control_2
No treatment with AST-120 in patients with CKD stage4 or 5.
Interventions/Control_3
No treatment with AST-120 in patients with normal kidney function.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age of patients is more than 20 years old.
Patients with normal kidney function or CKD stage 4 or 5.
Key exclusion criteria
Age of patients is less than 20 years old.
Patients during pregnancy.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Clinical Nephroscience
Zip code
Address
1-757 Ashahimachi-dori, Chuou-ku, Niigata, 951-8510, JAPAN
TEL
0252270436
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Clinical Nephroscience
Zip code
Address
1-757 Asahimachi-dori, Chuou-ku, Niigata, 951-8510Japan
TEL
0252270436
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 01 | Month | 15 | 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
| 2014 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014997
