Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT05010460
Status:
TERMINATED
Last Update Posted:
2025-12-09
First Post:
2021-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584543', 'term': 'roxadustat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'whyStopped': 'slow enrollment and inability to reach the planned sample size within the expected timeframe', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2021-08-07', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute kidney injury', 'timeFrame': '0-48 hours after surgery', 'description': 'elevation of serum creatinine ≥0.3mg/dl（26.5μmol/L）or ≥ 1.5 times baseline levels within 48 hours post surgery'}], 'secondaryOutcomes': [{'measure': 'classification of acute kidney injury', 'timeFrame': '0-3 days after surgery', 'description': 'classification of of acute kidney injury based on AKIN criteria'}, {'measure': 'renal function', 'timeFrame': '0-3 days after surgery', 'description': 'creatinine, urea, Cystatin-C after surgery'}, {'measure': 'new biomarkers of renal injury', 'timeFrame': 'immediately after surgery and the first morning after surgery', 'description': 'serum and urine NGAL，urine TIMP2\\*IGFBP7'}, {'measure': 'Cardiac Troponin Subunit I (cTnI)', 'timeFrame': '0-3 days after surgery', 'description': 'peak plasma concentration of cTnI and area under curve (AUC) of cTnI'}, {'measure': 'brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP)', 'timeFrame': '0-3 days after surgery', 'description': 'plasma concentration of BNP'}, {'measure': 'death', 'timeFrame': 'through study completion, an average of one month', 'description': 'death during hospitalization'}, {'measure': 'length of hospital stay and ICU stay', 'timeFrame': 'through study completion, an average of one month', 'description': 'length of hospital stay and ICU stay'}, {'measure': 'Blood infusion', 'timeFrame': '0-3 days after surgery', 'description': 'amount of Red blood cells infusion after surgery'}, {'measure': 'adverse events', 'timeFrame': 'through study completion, an average of one month', 'description': 'adverse events and severe adverse events during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute kidney injury', 'coronary artery bypass', 'Roxadustat'], 'conditions': ['Coronary Artery Bypass']}, 'referencesModule': {'references': [{'pmid': '16177006', 'type': 'BACKGROUND', 'citation': 'Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.'}, {'pmid': '18178798', 'type': 'BACKGROUND', 'citation': 'Hill P, Shukla D, Tran MG, Aragones J, Cook HT, Carmeliet P, Maxwell PH. Inhibition of hypoxia inducible factor hydroxylases protects against renal ischemia-reperfusion injury. J Am Soc Nephrol. 2008 Jan;19(1):39-46. doi: 10.1681/ASN.2006090998.'}, {'pmid': '30823476', 'type': 'BACKGROUND', 'citation': 'Shu S, Wang Y, Zheng M, Liu Z, Cai J, Tang C, Dong Z. Hypoxia and Hypoxia-Inducible Factors in Kidney Injury and Repair. Cells. 2019 Feb 28;8(3):207. doi: 10.3390/cells8030207.'}, {'pmid': '22262480', 'type': 'BACKGROUND', 'citation': 'Kapitsinou PP, Jaffe J, Michael M, Swan CE, Duffy KJ, Erickson-Miller CL, Haase VH. Preischemic targeting of HIF prolyl hydroxylation inhibits fibrosis associated with acute kidney injury. Am J Physiol Renal Physiol. 2012 May 1;302(9):F1172-9. doi: 10.1152/ajprenal.00667.2011. Epub 2012 Jan 18.'}, {'pmid': '31340089', 'type': 'BACKGROUND', 'citation': 'Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG). Roxadustat is a prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.\n\nThis study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.', 'detailedDescription': 'Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG), with a incidence of 28-38%. Renal ischemia-reperfusion injury is the main mechanism for acute kidney injury after CABG.\n\nRoxadustat is a kind of prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.\n\nThis study aims to evaluate the efficacy of administration of Roxadustat (before surgery) in the prevention of acute kidney injury after CABG. This is a multicenter, randomized, double-blind, placebo-controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* non-emergent CABG and planned cardiopulmonary bypass (CPB)\n* eGFR\\>15ml/min/1.73m2\n\nExclusion Criteria:\n\n* pregnancy or breast feeding\n* malignancy\n* severe liver dysfunction\n* acute kidney injury before randomization\n* uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT05010460', 'briefTitle': 'Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Roxadustat Reduces the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting: a Multicenter, Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'ROXAKI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Roxadustat', 'description': 'Roxadustat', 'interventionNames': ['Drug: Roxadustat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo has the same appearance with the experimental drug (Roxadustat).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Roxadustat', 'type': 'DRUG', 'otherNames': ['Evrenzo'], 'description': 'orally 100mg every other day for 5-8 days prior to CABG', 'armGroupLabels': ['Roxadustat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'orally 100mg every other day for 5-8 days prior to CABG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yan Qin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Qi Miao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '1 year after the end of this study', 'ipdSharing': 'YES', 'description': 'qualified researchers can request access to anonymized individual patient-level data by contacting principle investigator of this study, but this does not mean all requests will be shared by the investigators.', 'accessCriteria': 'please contact the investigators through email in the time frame'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}