Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:47 PM
Study NCT ID:
NCT01165567
Status:
UNKNOWN
Last Update Posted:
2010-07-20
First Post:
2010-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'C064294', 'term': 'sarpogrelate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-19', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of contrast-induced nephropathy', 'timeFrame': 'within 48 hours after using a contrast agent', 'description': 'The primary outcome of the study is the incidence of CIN, defined as either a greater than 25 percent increase of serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using a contrast agent'}], 'secondaryOutcomes': [{'measure': 'occurrence of CIN', 'timeFrame': 'at 4 weeks after using a contrast agent', 'description': 'Clinical endpoint measurements are conducted in-hospital and at 4 weeks. Cr concentration is measured at admission, every day for the next two days after contrast exposure, and at 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '35224730', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.'}, {'pmid': '31625293', 'type': 'DERIVED', 'citation': 'Ki YJ, Kwon SA, Kim HL, Seo JB, Chung WY. The Prevention of Contrast Induced Nephropathy by Sarpogrelate: a Prospective Randomized Controlled Clinical Trial. J Korean Med Sci. 2019 Oct 21;34(40):e261. doi: 10.3346/jkms.2019.34.e261.'}, {'pmid': '21167080', 'type': 'DERIVED', 'citation': 'Park K, Chung WY, Seo JB, Kim SH, Zo JH, Kim MA, Park YB. The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial. Trials. 2010 Dec 20;11:122. doi: 10.1186/1745-6215-11-122.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nContrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clear defined and debatable. Therefore additional prophylactic pretreatments are needed.\n\nMethods/Design:\n\nPresent study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.\n\nDiscussion:\n\nAs of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.', 'detailedDescription': 'All patients with CKD scheduled for CAG will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent. CKD is defined as estimated glomerular filtration rate (eGFR) \\<60 mL/min per 1.73 m2 using modification of diet in renal disease (MDRD) formula or serum creatinine (Cr) \\> 1.5 mg/dL.\n\nThe MDRD formula was defined in the following way. Where the Cr concentration is in mg/dL:\n\neGFR = 186 × serum Cr-1.154 × Age-0.203 × (0.742 if female) Exclusion criteria are age less than 20 years or more than 85 years, liver cirrhosis greater than or equal to Child class B, decreased serum platelet level (\\< 100,000/uL), patients who received or are schedule to receive percutaneous renal intervention, currently are taking anticoagulation drugs, unable to give informed consent. Patients in shock, maintaining hemodialysis, hemofiltration, peritoneal dialysis will be excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with chronic kidney disease scheduled for coronary angiogram\n\nExclusion Criteria:\n\n* age less than 20 years or more than 85 years\n* liver cirrhosis greater than or equal to Child class B\n* decreased serum platelet level (\\< 100,000/uL)\n* patients who received or are schedule to receive percutaneous renal intervention\n* currently are taking anticoagulation drugs\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01165567', 'briefTitle': 'The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Boramae Hospital'}, 'officialTitle': 'Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy', 'orgStudyIdInfo': {'id': '20091104/06-2009-123/89'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sarpogrelate 300 mg per day', 'description': 'Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.', 'interventionNames': ['Drug: sarpogrelate']}, {'type': 'NO_INTERVENTION', 'label': 'No sarpogrelate medication'}], 'interventions': [{'name': 'sarpogrelate', 'type': 'DRUG', 'otherNames': ['Anplag'], 'description': 'sarpogrelate, 300mg/day,duration: 4 weeks', 'armGroupLabels': ['sarpogrelate 300 mg per day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seoul National University Boramae Hospital', 'oldOrganization': 'Boramae Medical Center'}}}}