UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012838
Receipt No. 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

* 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 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
Email 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
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.