Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Phase 2

Recruiting

• Conditions: IgA Nephropathy
• Interventions: Biological: CM338

• Registration Number: NCT05775042
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.

Detailed Description

In 1968, immunoglobulin A nephropathy (IgAN) was developed by French pathologist Dr. Jean Berger and his colleague Dr. Nicole Hinglais that what is described as glomerular "immunoglobulin A (IgA)-immune globule" - immune globule Protein G (IgG) intercapillary deposition" of kidney disease, the main pathological feature of which is on the glomerulus IgA deposition, usually accompanied by local cell proliferation and stromal dilation. Since there is not enough specificity and spirit Biomarkers of sensitivity, the only way to confirm the diagnosis is renal biopsy.

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Study Start: 2023-05-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Male or female aged 18-75.
• Understand the nature of the study and sign the Informed Consent Form voluntarily.
• Take effective contraception measures throughout the study period.

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Exclusion Criteria

• Used other investigational drugs within 30 days before the first study administration.
• With previous history of Human immunodeficiency virus(HIV) infection.
• Treponema pallidum antibody positive in screening period.
• May have active Mycobacterium tuberculosis infection.
• Major surgery is planned during the study.
• Other reasons the investigator believes that the subject is not suitable to participate in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	CM338	CM338 will be injected subcutaneously.
Group A	CM338	CM338 will be injected subcutaneously.
Group B	CM338	CM338 will be injected subcutaneously.

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy	up to week 112	To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.

Trial Locations

Locations (1)

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