UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	AST-120 for functional abnormalities of HDL in patients with CKD
Title of the study (Brief title)	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	Suguru Yamamoto
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Clinical Nephroscience
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	Suguru Yamamoto
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Clinical Nephroscience
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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