Study of CM313 in Subject With IgA Nephropathy

NCT06830395 | Not Yet Recruiting Phase 2

• 1 other identifier: CM313-105101
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  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.

  Up to 108 weeks

Study Arms (8)

Part A: CM313 low dose

EXPERIMENTAL

Biological: CM313

Part A: CM313 high dose

EXPERIMENTAL

Biological: CM313

Part B: CM313 low dose with low frequency

EXPERIMENTAL

Biological: CM313

Part B: CM313 low dose with high frequency

EXPERIMENTAL

Biological: CM313

Part B: Placebo matching the volume of low dose CM313

PLACEBO COMPARATOR

Drug: Placebo

Part B: CM313 high dose with low frequency

EXPERIMENTAL

Biological: CM313

Part B: CM313 high dose with high frequency

EXPERIMENTAL

Biological: CM313

Part B: Placebo matching the volume of high dose CM313

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CM313 BIOLOGICAL

CM313(SC) injection

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

Placebo DRUG

Matched placebo

Part B: Placebo matching the volume of high dose CM313; Part B: Placebo matching the volume of low dose CM313

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jicheng Lv

  Peking University Frist Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (1)