Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

CM338 will be injected subcutaneously.

Group Type EXPERIMENTAL

CM338

Intervention Type BIOLOGICAL

CM338 injection

Group B

CM338 will be injected subcutaneously.

Group Type EXPERIMENTAL

CM338

Intervention Type BIOLOGICAL

CM338 injection

Group C

CM338 will be injected subcutaneously.

Group Type EXPERIMENTAL

CM338

Intervention Type BIOLOGICAL

CM338 injection

Interventions

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CM338

CM338 injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No