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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01157260
Enrollment
30
Registered
2010-07-07
Start date
2010-09-30
Completion date
2011-12-31
Last updated
2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Indoxyl sulfate, AST-120

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

Interventions

AST-120 2g three times a day

Sponsors

Ewha Womans University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of FMD(Flow Mediated Dilatation)6 monthsFMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.

Secondary

MeasureTime frame
Level of Indoxyl Sulfate3 months, 6 months

Countries

South Korea

Contacts

Primary ContactMINA YU, MD
yuelizabeth@hanmail.net+82-2-2650-2562
Backup ContactGil-Soon Yang, NR
40739@eumc.co.kr+82-2-2650-5132

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026