Study of CM313 in Subject With IgA Nephropathy

Phase 2

Not yet recruiting

• Conditions: IgA Nephropathy
• Interventions: Biological: CM313; Drug: Placebo

• Registration Number: NCT06830395
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Primary Completion: 2027-03
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Able to comprehend the research study and voluntarily signing the informed consent form (ICF).
• Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.
• Estimated Glomerular Filtration Rate (eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration formula) ≥ 30 mL/min/1.73 (m*m) at screening and baseline.
• 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.
• 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.

Exclusion Criteria

• 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.
• Known allergy to monoclonal antibody drugs or to the excipients of CM313.
• 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.
• Confirmed acute kidney injury (AKI) within 4 weeks prior to randomization.
• Vaccination of any live vaccine within 30 days prior to dosing or planned vaccination during the study period.
• History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo renal transplantation during the study.
• History of severe recurrent or chronic infection.
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: CM313 low dose	CM313	-
Part A: CM313 high dose	CM313	-
Part B: CM313 low dose with low frequency	CM313	-
Part B: CM313 low dose with high frequency	CM313	-
Part B: Placebo matching the volume of low dose CM313	Placebo	-
Part B: CM313 high dose with low frequency	CM313	-
Part B: CM313 high dose with high frequency	CM313	-
Part B: Placebo matching the volume of high dose CM313	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Up to 108 weeks	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.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing Municipality, China