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

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ClinicalTrials.gov Identifier: NCT01157260
Recruitment Status : Unknown
Verified March 2010 by Ewha Womans University.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Kremezin Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
Study Start Date : September 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AST-120
AST-120 administration 2g three times a day
Drug: Kremezin
AST-120 2g three times a day
Other Name: AST-120 (Kremezin) 2g three times a day
No Intervention: Control
Control Chronic Kidney disease stage 3,4


Outcome Measures

Primary Outcome Measures :
  1. Changes of FMD(Flow Mediated Dilatation) [ Time Frame: 6 months ]
    FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.


Secondary Outcome Measures :
  1. Level of Indoxyl Sulfate [ Time Frame: 3 months, 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157260


Contacts
Contact: MINA YU, MD +82-2-2650-2562 yuelizabeth@hanmail.net
Contact: Gil-Soon Yang, NR +82-2-2650-5132 40739@eumc.co.kr

Locations
Korea, Republic of
Ewha Womans University Mokdong Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Mina Yu, MD    +82-2-2650-2562    yuelizabeth@hanmail.net   
Contact: Gil-Soon Yang, NR    +82-2-2650-5132      
Principal Investigator: Duk-Hee Kang, MD, PhD         
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Duk-Hee Kang, MD. PhD. Ewha Womans University
More Information

Responsible Party: Nephrology, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT01157260     History of Changes
Other Study ID Numbers: Ewha AST-120
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: March 2010

Keywords provided by Ewha Womans University:
Indoxyl sulfate
AST-120

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases