Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01364402
Status:
UNKNOWN
Last Update Posted:
2012-10-10
First Post:
2011-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Contrast Induced Nephropathy by Erythropoietin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'C103998', 'term': 'epoetin beta'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-09', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Contrast Induced Nephropathy(CIN)', 'timeFrame': '1-3 days after exposure to contrast media'}], 'secondaryOutcomes': [{'measure': 'Enzymatic infarct size', 'timeFrame': '6h and 12 h after exposure to contrast media', 'description': 'Will be measured by Troponin and CK'}, {'measure': 'Hospital length of stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days'}, {'measure': 'Renal replacement therapy', 'timeFrame': 'participants will be followed after PCI procedure till discharge, an expected average of 1-2 days'}, {'measure': 'Hospital mortality', 'timeFrame': 'participants will be followed after PCI procedure till discharge, an expected average of 1-2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['scheduled for PCI'], 'conditions': ['Diabetes', 'Chronic Kidney Insufficiency']}, 'referencesModule': {'references': [{'pmid': '39301879', 'type': 'DERIVED', 'citation': 'Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.\n\nThe investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.', 'detailedDescription': "Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).\n\nThe potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age.\n* Diabetic patients.\n* eGFR \\< 60 ml/min/1.73m2.\n* Scheduled for primary or elective PCI.\n\nExclusion Criteria:\n\n* Non diabetic patients.\n* Patients with eGFR ≥ 60 ml/min/1.73m2.\n* Chronic renal replacement therapy.\n* Subject with active malignancy.\n* Subject with any known history of seizure disorders.\n* Subject with polycythemia.\n* Uncontrolled hypertension.\n* Known allergy or hypersensitivity to EPO.\n* Use of EPO 1 week prior to randomization.\n* Use of long acting EPO (CERA) during 1 month prior to randomization.\n* Use of NAC or bicarbonate during 3 days prior to randomization.\n* Contrast media exposure during the last 7 days before randomization.\n* Pregnant or lactating women.\n* Participation in other clinical trial.\n* Refusal or inability to give informed consent due to mental or physical state.'}, 'identificationModule': {'nctId': 'NCT01364402', 'briefTitle': 'Prevention of Contrast Induced Nephropathy by Erythropoietin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'EPO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin', 'interventionNames': ['Drug: Epoetin beta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Saline 0.9%']}], 'interventions': [{'name': 'Epoetin beta', 'type': 'DRUG', 'otherNames': ['Epoietin beta'], 'description': '50,000U intravenously', 'armGroupLabels': ['Erythropoietin']}, {'name': 'Saline 0.9%', 'type': 'DRUG', 'otherNames': ['Hydration'], 'description': 'normal saline intravenously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nahariya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shaul Atar, MD', 'role': 'CONTACT', 'email': 'shaul.atar@naharia.health.gov.il'}, {'name': 'Batya Kristal, MD', 'role': 'CONTACT', 'email': 'batya.kristal@naharia.health.gov.il'}, {'name': 'Shaul Atar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Batya Kristal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lilach Shema-Didi, RN, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irith Weissman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ronit Geron, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'centralContacts': [{'name': 'Lilach Shema-Didi, RN, MPH', 'role': 'CONTACT', 'email': 'lilach_01@yahoo.com', 'phone': '972-507887538'}, {'name': 'Lilach Shema-Didi, RN, MPH', 'role': 'CONTACT', 'email': 'Lilach.Shema-Didi@naharia.health.gov.il'}], 'overallOfficials': [{'name': 'Shaul Atar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Galilee Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Shaul Atar', 'oldOrganization': 'Western Galilee Hospital'}}}}