The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease

NCT ID: NCT01157260

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

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Indoxyl sulfate (IS) is a uremic toxin that accelerates the progression of chronic kidney disease (CKD). AST-120 (Kremezin®; Kureha Corporation, Tokyo, Japan) removes indole, which is the precursor of IS, in the intestine, and reduces the accumulation of IS. This drug has been shown to retard the deterioration of renal function in CKD patients through reducing the levels of IS.

IS was reported to promote aortic calcification and stimulate the proliferation of vascular smooth muscle cells (VSMC). IS also inhibits endothelial proliferation and wound repair. With this background, the investigators will performed the study whether AST-120 improve the endothelial dysfunction in CKD patients.

Detailed Description

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The purpose of this study is to examine whether Kremezin, Indoxyl sulfate lowering agent improve endothelial dysfunction in stage 3,4 chronic kidney disease patients

Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AST-120

AST-120 administration 2g three times a day

Group Type EXPERIMENTAL

Kremezin

Intervention Type DRUG

AST-120 2g three times a day

Control

Control Chronic Kidney disease stage 3,4

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kremezin

AST-120 2g three times a day

Intervention Type DRUG

Other Intervention Names

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AST-120 (Kremezin) 2g three times a day

Eligibility Criteria

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Inclusion Criteria

* Patients with Chronic kidney disease (Stage3 - Stage4)
* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria

* Acute gastric or duodenal ulcer
* Severe constipation
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Ewha Womans University Mokdong Hospital

Principal Investigators

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Duk-Hee Kang, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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MINA YU, MD

Role: CONTACT

+82-2-2650-2562

Gil-Soon Yang, NR

Role: CONTACT

+82-2-2650-5132

Facility Contacts

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Mina Yu, MD

Role: primary

+82-2-2650-2562

Gil-Soon Yang, NR

Role: backup

+82-2-2650-5132

Other Identifiers

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Ewha AST-120

Identifier Type: -

Identifier Source: org_study_id

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