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 is a randomized, double-blind, placebo-controlled phase II clinical study evaluating the safety and efficacy of CM313 (SC) in subjects with IgA nephropathy

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Study Start: 2025-03
• Primary Completion: 2026-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Able to comprehend the research study and voluntarily signing the informed consent form (ICF).
2. Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.
3. Estimated glomerular filtration rate (eGFR) >=30 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening.
4. Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor [ACE-I] or angiotensin receptor blocker [ARB]) for 12 weeks prior to screening.

Exclusion Criteria

1. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
2. Known or suspected hypersensitivity to excipients used in CM313.
3. Rapidly progressive glomerulonephritis (RPGN), defined as a decrease of eGFR by more than 50% within 3 months prior to Baseline Visit and/or formation of crescents in more than 50% of glomeruli in renal paracentesis specimens.
4. Confirmed acute kidney injury (AKI) within 4 weeks prior to Baseline Visit.
5. Receipt of live attenuated vaccine within 30 days prior to the Baseline Visit or plan to receive such a vaccine during the study; receipt of novel coronavirus vaccines within 7 days prior to study drug administration.
6. History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo transplantation during the study.
7. History of severe recurrent or chronic infection.
8. Current malignancy or history of malignancy during the previous 5 years, except adequately treated basal cell or squamous cell carcinomas of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	-
Group 2	CM313	-
Group 2	Placebo	-
Group 3	Placebo	-
Group 1	CM313	-
Group 3	CM313	-

Primary Outcome Measures

Name	Time	Method
Adverse event	Up to Week 24	The occurrence of adverse events.
Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR)	Up to Week 24	Percent Change from Baseline in UPCR