Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-30 @ 5:21 AM
Study NCT ID:
NCT01157260
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2010-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C040896', 'term': 'AST 120'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of FMD(Flow Mediated Dilatation)', 'timeFrame': '6 months', 'description': 'FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery.'}], 'secondaryOutcomes': [{'measure': 'Level of Indoxyl Sulfate', 'timeFrame': '3 months, 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Indoxyl sulfate', 'AST-120'], 'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': '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.\n\nIS 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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Chronic kidney disease (Stage3 - Stage4)\n* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information\n\nExclusion Criteria:\n\n* Acute gastric or duodenal ulcer\n* Severe constipation'}, 'identificationModule': {'nctId': 'NCT01157260', 'briefTitle': 'The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'Ewha AST-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AST-120', 'description': 'AST-120 administration 2g three times a day', 'interventionNames': ['Drug: Kremezin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control Chronic Kidney disease stage 3,4'}], 'interventions': [{'name': 'Kremezin', 'type': 'DRUG', 'otherNames': ['AST-120 (Kremezin) 2g three times a day'], 'description': 'AST-120 2g three times a day', 'armGroupLabels': ['AST-120']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Mina Yu, MD', 'role': 'CONTACT', 'email': 'yuelizabeth@hanmail.net', 'phone': '+82-2-2650-2562'}, {'name': 'Gil-Soon Yang, NR', 'role': 'CONTACT', 'phone': '+82-2-2650-5132'}, {'name': 'Duk-Hee Kang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'MINA YU, MD', 'role': 'CONTACT', 'email': 'yuelizabeth@hanmail.net', 'phone': '+82-2-2650-2562'}, {'name': 'Gil-Soon Yang, NR', 'role': 'CONTACT', 'email': '40739@eumc.co.kr', 'phone': '+82-2-2650-5132'}], 'overallOfficials': [{'name': 'Duk-Hee Kang, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nephrology', 'oldOrganization': 'Ewha Womans University Mokdong Hospital'}}}}