Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Keymed Biosciences

Status and phase: Enrolling; Phase 2

Conditions: IgA Nephropathy

Treatments: Biological: CM338

Study type: Interventional

Funder types: Industry

Identifiers

NCT05775042

CM338-105101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Group A

Experimental group

Description:

CM338 will be injected subcutaneously.

Treatment:

Biological: CM338

Group B

Experimental group

Description:

CM338 will be injected subcutaneously.

Treatment:

Biological: CM338

Group C

Experimental group

Description:

CM338 will be injected subcutaneously.

Treatment:

Biological: CM338