Back to resultsThe Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
Primary Purpose
Kidney Failure, Chronic
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Kremezin
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Indoxyl sulfate, AST-120
Eligibility 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
Sites / Locations
- Ewha Womans University Mokdong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AST-120
Control
Arm Description
AST-120 administration 2g three times a day
Control Chronic Kidney disease stage 3,4
Outcomes
Primary Outcome Measures
Changes of FMD(Flow Mediated Dilatation)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01157260
Brief Title
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
Official Title
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Indoxyl sulfate, AST-120
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AST-120
Arm Type
Experimental
Arm Description
AST-120 administration 2g three times a day
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Chronic Kidney disease stage 3,4
Intervention Type
Drug
Intervention Name(s)
Kremezin
Other Intervention Name(s)
AST-120 (Kremezin) 2g three times a day
Intervention Description
AST-120 2g three times a day
Primary Outcome Measure Information:
Title
Changes of FMD(Flow Mediated Dilatation)
Description
FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Level of Indoxyl Sulfate
Time Frame
3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MINA YU, MD
Phone
+82-2-2650-2562
Email
yuelizabeth@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Gil-Soon Yang, NR
Phone
+82-2-2650-5132
Email
40739@eumc.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-Hee Kang, MD. PhD.
Organizational Affiliation
Ewha Womans University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina Yu, MD
Phone
+82-2-2650-2562
Email
yuelizabeth@hanmail.net
First Name & Middle Initial & Last Name & Degree
Gil-Soon Yang, NR
Phone
+82-2-2650-5132
First Name & Middle Initial & Last Name & Degree
Duk-Hee Kang, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
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