Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06949020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2025-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004489', 'term': 'Edema, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': '5 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fluid retention', 'heart failure'], 'conditions': ['Cardiac Edema']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;\n2. Age ≥ 18 years old when signing the informed consent form;\n3. At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion;\n4. The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:\n\n1\\) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.\n\n5\\. After the background treatment in the run-in period, the subject still has the following two conditions:\n\n1. One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion;\n2. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.\n\nExclusion Criteria:\n\n1. Edema caused by diseases other than heart failure；\n2. Subjects with ventricular assist devices during screening;\n3. Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;\n4. Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction);\n5. Subjects with hypovolemia or suspected hypovolemia;\n6. Subject cannot feel thirst or have difficulty in fluid intake during screening;\n7. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;\n8. Administered with tolvaptan 14days before randomization ；\n9. Pregnancy (female pregnancy test positive) or lactation period;'}, 'identificationModule': {'nctId': 'NCT06949020', 'briefTitle': 'A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jemincare'}, 'officialTitle': 'Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'JMKX003142-H201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dose group', 'interventionNames': ['Drug: JMKX003142 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'median dose group', 'interventionNames': ['Drug: JMKX003142 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'high dose group', 'interventionNames': ['Drug: JMKX003142 Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'interventionNames': ['Drug: JMKX003142 placebo']}], 'interventions': [{'name': 'JMKX003142 Injection', 'type': 'DRUG', 'description': 'JMKX003142 injection for experimental groups once daily for five days.', 'armGroupLabels': ['high dose group']}, {'name': 'JMKX003142 Injection', 'type': 'DRUG', 'description': 'JMKX003142 injection for experimental groups once daily for five days.', 'armGroupLabels': ['low dose group']}, {'name': 'JMKX003142 Injection', 'type': 'DRUG', 'description': 'JMKX003142 injection for experimental groups once daily for five days.', 'armGroupLabels': ['median dose group']}, {'name': 'JMKX003142 placebo', 'type': 'DRUG', 'description': 'JMKX003142 placebo for placebo groups once daily for five days.', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yang Zhang', 'role': 'CONTACT', 'email': 'zhangyang@jemincare.com', 'phone': '+8618768467776'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jemincare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}