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

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 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


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

Value
https://center6.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