Tests CM313 injection in adults with IgA nephropathy kidney disease
Tests the CM313 injection against a placebo in adults with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: Study of CM313 in Subject With IgA Nephropathy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06830395, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Keymed Biosciences Co.Ltd
- Trial code
- NCT06830395
- Record updated
- 19 September 2025
- Original description
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.Read full original descriptionShow less
A Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With Primary IgA Nephropathy
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.
Inclusion: 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: 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; 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); 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; 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; 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.