Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:47 AM
Study NCT ID:
NCT07354932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SHR-2173 in Participants With Primary IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.', 'timeFrame': 'Week 24.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in 24-hour UPCR ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Change from baseline in 24-hour urinary protein quantification ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Change from baseline in estimated Glomerular Filtration Rate (eGFR) ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Change from baseline in hematuria ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Change from baseline in serum creatinine ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Proportion of participants achieving clinical remission;', 'timeFrame': 'up to Week 48'}, {'measure': 'Annualized total eGFR slope from baseline ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Proportion of participants meeting composite endpoints ;', 'timeFrame': 'up to Week 48'}, {'measure': 'Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ;', 'timeFrame': 'up to Week 48'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary IgA Nephropathy']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female participants aged 18 or older\n2. Body weight ≥35 kg, BMI\\<37.5 kg/m2\n3. At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g\n4. eGFR≥30 mL/ minute /1.73 m2 at screening\n5. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol\n\nExclusion Criteria:\n\n\\-\n\n1、Presence of any of the following medical histories or comorbidities:\n\n1. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;\n2. A history of organ transplantation;\n3. A history of splenectomy;\n4. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);\n5. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug\n\n2、Use of any of the following drugs/treatments or participation in a clinical study:\n\n1. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);\n2. Receivied immunosuppressive therapy within 12 weeks before randomization;\n3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;\n4. Received a live / attenuated live vaccine administered within 4 weeks before randomization\n\n3、History and examination related to infection:\n\n1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization;\n2. Tuberculosis (TB) or occult TB infection (one of the following conditions) :\n\n 1. Presence of active TB or clinical symptoms of active TB at screening;\n 2. Signs of active TB on imaging examination within 3 months before screening\n\n 4、 General situation:\n\n1\\) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.'}, 'identificationModule': {'nctId': 'NCT07354932', 'briefTitle': 'A Study of SHR-2173 in Participants With Primary IgA Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy', 'orgStudyIdInfo': {'id': 'SHR-2173-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A: SHR-2173 injection', 'interventionNames': ['Drug: SHR-2173 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B: SHR-2173 injection', 'interventionNames': ['Drug: SHR-2173 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group C: SHR-2173 injection', 'interventionNames': ['Drug: SHR-2173 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR-2173 injection', 'type': 'DRUG', 'description': 'SHR-2173 injection；High dose', 'armGroupLabels': ['Treatment group A: SHR-2173 injection']}, {'name': 'SHR-2173 injection', 'type': 'DRUG', 'description': 'SHR-2173 injection；Medium dose', 'armGroupLabels': ['Treatment group B: SHR-2173 injection']}, {'name': 'SHR-2173 injection', 'type': 'DRUG', 'description': 'SHR-2173 injection；Low dose', 'armGroupLabels': ['Treatment group C: SHR-2173 injection']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Wei Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Jingyuan Xie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Kunming Li', 'role': 'CONTACT', 'email': 'kunming.li@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}