Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05775042

Enrollment

Registered

2023-03-20

Start date

2023-05-08

Completion date

2027-06-30

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

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.

Interventions

BIOLOGICALCM338

CM338 injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactQian Jia

qianjia@keymedbio.com028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026