The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
AST-120 administration 2g three times a day
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
- 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.
- Level of Indoxyl Sulfate [ Time Frame: 3 months, 6 months ]
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
|Contact: MINA YU, MDfirstname.lastname@example.org|
|Contact: Gil-Soon Yang, NRemail@example.com|
|Korea, Republic of|
|Ewha Womans University Mokdong Hospital||Not yet recruiting|
|Seoul, Korea, Republic of|
|Contact: Mina Yu, MD +82-2-2650-2562 firstname.lastname@example.org|
|Contact: Gil-Soon Yang, NR +82-2-2650-5132|
|Principal Investigator: Duk-Hee Kang, MD, PhD|
|Principal Investigator:||Duk-Hee Kang, MD. PhD.||Ewha Womans University|