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

Ewha Womans University

Status and phase: Unknown; Phase 4

Conditions: Kidney Failure, Chronic

Treatments: Drug: Kremezin

Study type: Interventional

Funder types: Other

Identifiers

NCT01157260

Ewha AST-120

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

AST-120

Experimental group

Description:

AST-120 administration 2g three times a day

Treatment:

Drug: Kremezin

Control

No Intervention group

Description:

Control Chronic Kidney disease stage 3,4