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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Ewha Womans University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01157260
First received: June 25, 2010
Last updated: July 6, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Kidney Failure, Chronic
Drug: Kremezin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

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


Secondary Outcome Measures:
  • Level of Indoxyl Sulfate [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nephrology, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT01157260     History of Changes
Other Study ID Numbers: Ewha AST-120
Study First Received: June 25, 2010
Last Updated: July 6, 2010
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014