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

Phase 4
Conditions
Kidney Failure, Chronic
Interventions
Registration Number
NCT01157260
Lead Sponsor
Ewha Womans University
Brief Summary

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

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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AST-120KremezinAST-120 administration 2g three times a day
Primary Outcome Measures
NameTimeMethod
Changes of FMD(Flow Mediated Dilatation)6 months

FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.

Secondary Outcome Measures
NameTimeMethod
Level of Indoxyl Sulfate3 months, 6 months

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital

🇰🇷

Seoul, Korea, Republic of

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