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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01157260
• Other study ID #: Ewha AST-120
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 25, 2010
• Last updated: July 6, 2010
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: Ewha Womans University
• Contact: MINA YU, MD
• Phone: +82-2-2650-2562
• Email: yuelizabeth[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Kremezin
AST-120 2g three times a day

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of FMD(Flow Mediated Dilatation)	FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.	6 months	Yes
Secondary	Level of Indoxyl Sulfate		3 months, 6 months	No