Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-11 @ 8:04 AM
Study NCT ID:
NCT05053893
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2021-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059347', 'term': 'Cardio-Renal Syndrome'}], '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': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-09-12', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of hemoglobin level before and after treatment', 'timeFrame': 'Day0-Day90', 'description': 'By detecting blood routine,calculate the changes of hemoglobin.Change value of hemoglobin level(g/L) = baseline hemoglobin level(g/L) - hemoglobin level after treatment(g/L)'}, {'measure': 'Changes of ejection fraction before and after treatment', 'timeFrame': 'Day0-Day90', 'description': 'Cardiac ejection fraction was measured by cardiac ultrasound before and after treatment，and change of cardiac ejection fraction(%) = baseline cardiac ejection fraction level(%) - post-treatment cardiac ejection fraction level(%)'}, {'measure': 'Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment', 'timeFrame': 'Day0-Day90', 'description': 'Incidence rate = number of patients with the events/ total number of patients included in the study in this group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardio-Renal Syndrome']}, 'descriptionModule': {'briefSummary': 'A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as regular dialysis patients with cardiorenal anemia syndrome\n* Hemoglobin 60-110g / L (twice with an interval of at least 4 days);\n* Volunteered to participate\n\nExclusion Criteria:\n\n* Anemia caused by diseases other than CKD\n* Malignant tumors\n* Active liver disease\n* Rheumatic immune diseases in active stage\n* Hereditary or idiopathic angioedema\n* Systolic blood pressure≥180 mmHg;diastolic blood pressure≥110 mmHg\n* Acute myocardial infarction and unstable angina pectoris\n* Severe parathyroidism\n* Active peptic ulcer\n* taking aliskiren\n* Mental disease\n* Alcohol and drug abuse\n* Allergy to test drugs'}, 'identificationModule': {'nctId': 'NCT05053893', 'briefTitle': 'Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome', 'orgStudyIdInfo': {'id': 'XHASB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)', 'description': 'Roxadustat(FibroGen, China), 100mg (45-60kg) or 120mg (≥ 60kg) each time, three times a week, orally on an empty stomach in the morning. The initial dose of Sacubitril Valsartan Sodium Tablets(Novartis, China) is 50mg, once a day, taken on an empty stomach in the morning, and gradually titrated from the minimum dose to the maximum tolerated dose.', 'interventionNames': ['Drug: Roxadustat;Sacubitril Valsartan Sodium Tablets;']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional treatment group(EPO combined with ACEI or ARB )', 'description': 'Recombinant human erythropoietin (SEBOR, 10000 units / Branch) was injected subcutaneously once a week; Perindopril tablets (Servier, China), taken on an empty stomach, gradually titrated from the minimum dose to the maximum tolerated dose.', 'interventionNames': ['Drug: EPO; ACEI / ARB']}], 'interventions': [{'name': 'Roxadustat;Sacubitril Valsartan Sodium Tablets;', 'type': 'DRUG', 'otherNames': ['Entresto®'], 'description': "Select the appropriate dose according to the patient's situation", 'armGroupLabels': ['New treatment group(Roxadustat combined with Sacubitril Valsartan Sodium Tablets)']}, {'name': 'EPO; ACEI / ARB', 'type': 'DRUG', 'description': "Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication", 'armGroupLabels': ['Traditional treatment group(EPO combined with ACEI or ARB )']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'state': 'Shangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gungqun Xing, Doctor', 'role': 'CONTACT', 'email': 'gqx99monash@163.com', 'phone': '186661802178'}], 'facility': 'Department of Nephrology, Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Guangqun Xing, Doctor', 'role': 'CONTACT', 'email': 'gqx99monash@163.com', 'phone': '18661802178'}, {'name': 'Ting Li, Master', 'role': 'CONTACT', 'email': 'lt20080607@126.com', 'phone': '18661801532'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician; Professor', 'investigatorFullName': 'Guangqun Xing,MD', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}