Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:21 AM
Study NCT ID:
NCT07318103
Status:
RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in weight from baseline on day 8', 'timeFrame': 'within 8 days after the start of administration'}], 'secondaryOutcomes': [{'measure': 'Absolute change in body weight from baseline at each visit during treatment', 'timeFrame': 'At each visit during treatment，within 8 days after the start of administration'}, {'measure': 'The proportion of participants requiring remedial treatment during therapy as defined by the protocol', 'timeFrame': 'after the last case has left the group，within 1years after the first case in'}, {'measure': 'Total dose of loop diuretics during treatment', 'timeFrame': 'within 8 days after the start of administration'}, {'measure': 'The incidence and severity of any adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) occurring after any treatment', 'timeFrame': 'within 8 days after the start of administration'}, {'measure': 'Incidence of hypernatraemia during treatment', 'timeFrame': 'within 8 days after the start of administration'}, {'measure': 'Proportion of participants who experienced hypovolaemic events during treatment and needed to discontinue the trial medication', 'timeFrame': 'within 8 days after the start of administration'}, {'measure': 'Detection indicators: concentrations of HRS-9057, tolvaptan and other major metabolites (if applicable)', 'timeFrame': 'within 8 days after the start of administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluid Retention Caused by Heart Failure']}, 'descriptionModule': {'briefSummary': 'Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 years on the day of signing the informed consent, regardless of gender;\n2. Hospitalised for acute heart failure within 24 hours prior to randomisation;\n3. Presence of heart failure symptoms before randomisation (exertional dyspnoea, nocturnal paroxysmal dyspnoea, orthopnoea, etc.) and at least one sign of fluid retention, including: pulmonary rales on auscultation, pitting oedema of the lower limbs, pulmonary congestion confirmed by chest imaging;\n4. NT-proBNP \\>450 pg/mL within 12 hours prior to randomisation, \\>600 pg/mL for patients with atrial fibrillation;\n5. Judged to have poor response to loop diuretics before randomisation: presence of symptoms and signs of fluid retention after the administration of a cumulative dose of oral or intravenous loop diuretics equivalent to oral furosemide ≥40 mg (or equivalent doses of other loop diuretics#) within the past 12 hours.\n\nExclusion Criteria:\n\n1. Myocardial infarction, stroke or transient cerebral ischaemic attack, sustained ventricular tachycardia or ventricular fibrillation within 1 month prior to screening; or severe infection, major trauma or undergoing major or medium-sized surgery within 1 month prior to screening;\n2. Coronary revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), atrial flutter/fibrillation ablation, pacemaker implantation, valve repair/replacement, carotid or peripheral artery revascularisation, cardiac mechanical assist device therapy, heart transplantation within 1 month prior to screening or planned during the trial; or current severe coronary artery disease or cerebrovascular disease without revascularisation;\n3. Fluid retention symptoms and signs judged by the investigator to be caused by non-cardiac diseases; or concomitant conditions causing dyspnoea or fluid retention, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary heart disease, severe anaemia, decompensated liver cirrhosis, nephrotic syndrome, etc.;\n4. Acute heart failure requiring primary correction of the underlying cause as determined by the investigator, due to the following conditions: coronary atherosclerotic heart disease requiring revascularisation, active myocarditis, constrictive pericarditis, cardiac tamponade, complex congenital heart disease, untreated severe primary valvular heart disease, etc.;\n5. Previously diagnosed hypertrophic cardiomyopathy (obstructive or non-obstructive), amyloid cardiomyopathy;\n6. Use of cardiac mechanical assist device at the time of screening;\n7. Hypovolaemia or peripheral perfusion insufficiency at the time of screening, requiring vasoactive drugs, positive inotropic drugs or volume expansion therapy as assessed by the investigator;\n8. Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours;\n9. Unable to perceive thirst at the time of screening, or any reason causing difficulty in fluid intake;\n10. Unable to complete weight measurement or urine collection;\n11. Consciousness impairment at the time of screening, or hepatic encephalopathy at the time of screening or a history of hepatic encephalopathy;\n12. Poorly controlled diabetes at the time of screening, with fasting blood glucose ≥11.1mmol/L;\n13. Any organ system malignancy within the last 5 years requiring ongoing treatment such as chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc.;\n14. History of drug abuse or substance use within 1 year prior to screening.\n15. Body mass index (BMI) less than 18.5 or greater than 35 kg/m2;\n16. Symptomatic hypotension and/or systolic blood pressure \\<90 mmHg;\n17. Estimated glomerular filtration rate (eGFR) \\<15 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI2009\\] formula based on serum creatinine), or undergoing/planned for haemodialysis or ultrafiltration therapy;\n18. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× the upper limit of normal (ULN), except if assessed by the investigator as due to heart failure;\n19. Serum sodium \\> ULN or \\<130 mmol/L;\n20. Serum potassium \\> ULN or serum potassium still \\< lower limit of normal (LLN) after treatment;\n21. Concurrent active hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive and peripheral blood hepatitis B virus DNA positive) or any one of human immunodeficiency virus antibodies (HIV-Ab), Treponema pallidum antibodies (Anti-TP), hepatitis C virus antibodies (HCV-Ab) positive.\n22. Known or suspected allergy to tolvaptan tablets, OPC-61815 injection, or HRS-9057 injection components;\n23. Participation in any drug or medical device clinical trial within 3 months prior to screening, defined as: signing the informed consent and using the investigational product (excluding placebo) or investigational medical device; or still within 5 half-lives of the investigational drug (whichever is longer);\n24. Use of tolvaptan tablets, OPC-61815 injection, or thiazide diuretics (including combination formulations) within 5 half-lives before dosing;\n25. Use of drugs that may affect tolvaptan metabolism within 2 weeks or 5 half-lives before dosing (whichever is longer), includin\n\n ⅰ strong or moderate CYP3A inhibitors: ketoconazole or other strong CYP3A inhibitors (such as clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir, nefazodone), moderate CYP3A inhibitors (such as erythromycin, fluconazole, aprepitant, diltiazem, verapamil, delavirdine);\n\n ⅱ CYP3A inducers: rifampicin or other inducers (such as rifabutin, rifapentine, barbiturates, phenytoin, carbamazepine, forsythia);\n\n ⅲ P-glycoprotein inhibitors: such as cyclosporine;\n26. History of blood donation or blood loss ≥400 mL within 3 months prior to screening, or blood transfusion within 2 months;\n27. Participants with mental incapacity or speech disorders, or unable to fully understand or participate in the trial process, or unable to fully understand potential adverse reactions during the study;\n28. Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use protocol-specified contraception during the trial and for 1 week after the last dose;\n29. As judged by the investigator, any condition affecting participant safety or otherwise interfering with the evaluation of trial results (medical, psychological, social, or geographical factors, etc.).'}, 'identificationModule': {'nctId': 'NCT07318103', 'briefTitle': 'Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujian Shengdi Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicentre, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Injectable HRS-9057 in Patients With Heart Failure-induced Fluid Retention', 'orgStudyIdInfo': {'id': 'HRS-9057-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-9057 for injection', 'interventionNames': ['Drug: HRS-9057 injection set']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5% Glucose Injection', 'interventionNames': ['Drug: 5% Glucose Injection']}], 'interventions': [{'name': 'HRS-9057 injection set', 'type': 'DRUG', 'description': 'HRS-9057 injection set', 'armGroupLabels': ['HRS-9057 for injection']}, {'name': '5% Glucose Injection', 'type': 'DRUG', 'description': '5% Glucose Injection', 'armGroupLabels': ['5% Glucose Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuhui Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fuwai Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Na Li', 'role': 'CONTACT', 'email': 'na.li.nl80@hengrui.com', 'phone': '+0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Shengdi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}