Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 9:48 PM
Study NCT ID:
NCT06830395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CM313 in Subject With IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 106}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 108 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy']}, 'descriptionModule': {'briefSummary': 'This study is divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to comprehend the research study and voluntarily signing the informed consent form (ICF).\n* Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.\n* Estimated Glomerular Filtration Rate (eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration formula) ≥ 30 mL/min/1.73 (m\\*m) at screening and baseline.\n* Prior to the baseline visit, all subjects must have received standard care treatment, including good blood pressure control and a stable treatment of a maximum recommended or maximum tolerated dose of angiotensin-converting enzyme inhibitors(ACEI) or Angiotensin receptor blocker(ARB) for at least 12 weeks.\n* 24-hour urinary protein-to-creatinine ratio (24h-UPCR) ≥ 0.75 g/g or 24-hour urinary protein excretion (24h-UPE) ≥ 1 g/d during the screening and baseline periods.\n\nExclusion Criteria:\n\n* Secondary IgAN judged by the investigator: Secondary IgAN may be associated with Henoch-Schonlein purpura, hepatic cirrhosis, coeliac disease, human immunodeficiency virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small cell carcinoma, lymphoma, disseminated tuberculosis, obliterative bronchiolitis, inflammatory bowel disease, familial Mediterranean fever, etc.\n* Known allergy to monoclonal antibody drugs or to the excipients of CM313.\n* Presence of rapidly progressive glomerulonephritis (RPGN), defined as 50% decline in eGFR within 3 months prior to randomization and/or crescent formation in more than 50% of glomeruli in a renal pathological specimen.\n* Confirmed acute kidney injury (AKI) within 4 weeks prior to randomization.\n* Vaccination of any live vaccine within 30 days prior to dosing or planned vaccination during the study period.\n* History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo renal transplantation during the study.\n* History of severe recurrent or chronic infection.\n* Malignant tumor within 5 years prior to screening (except for completely cured cervix carcinoma in situ and non-skin squamous cell carcinoma metastatic or basal cell carcinoma).'}, 'identificationModule': {'nctId': 'NCT06830395', 'briefTitle': 'Study of CM313 in Subject With IgA Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keymed Biosciences Co.Ltd'}, 'officialTitle': 'A Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With Primary IgA Nephropathy', 'orgStudyIdInfo': {'id': 'CM313-105101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: CM313 low dose', 'interventionNames': ['Biological: CM313']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: CM313 high dose', 'interventionNames': ['Biological: CM313']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CM313 low dose with low frequency', 'interventionNames': ['Biological: CM313']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CM313 low dose with high frequency', 'interventionNames': ['Biological: CM313']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo matching the volume of low dose CM313', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CM313 high dose with low frequency', 'interventionNames': ['Biological: CM313']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CM313 high dose with high frequency', 'interventionNames': ['Biological: CM313']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo matching the volume of high dose CM313', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CM313', 'type': 'BIOLOGICAL', 'description': 'CM313(SC) injection', 'armGroupLabels': ['Part A: CM313 high dose', 'Part A: CM313 low dose', 'Part B: CM313 high dose with high frequency', 'Part B: CM313 high dose with low frequency', 'Part B: CM313 low dose with high frequency', 'Part B: CM313 low dose with low frequency']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo', 'armGroupLabels': ['Part B: Placebo matching the volume of high dose CM313', 'Part B: Placebo matching the volume of low dose CM313']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qian Jia', 'role': 'CONTACT', 'email': 'qianjia@keymedbio.com', 'phone': '028-88610620'}], 'overallOfficials': [{'name': 'Jicheng Lv', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Frist Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keymed Biosciences Co.Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}