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

NCT01157260 | Unknown Phase 4 DMC

• 1 other identifier: Ewha AST-120
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic

Keywords

Indoxyl sulfate; AST-120

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Level of Indoxyl Sulfate

  3 months, 6 months

Study Arms (2)

AST-120

EXPERIMENTAL

AST-120 administration 2g three times a day

Drug: Kremezin

Control

NO INTERVENTION

Control Chronic Kidney disease stage 3,4

Interventions

Kremezin DRUG

AST-120 2g three times a day

Also known as: AST-120 (Kremezin) 2g three times a day

AST-120

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute gastric or duodenal ulcer
• Severe constipation

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

AST 120

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Duk-Hee Kang, MD. PhD.

  Ewha Womans University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MINA YU, MD

CONTACT

+82-2-2650-2562; yuelizabeth@hanmail.net

Gil-Soon Yang, NR

CONTACT

+82-2-2650-5132; 40739@eumc.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 7, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 7, 2010

Record last verified: 2010-03

Locations

KR (1)