Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775042
• Other study ID #: CM338-105101
• Status: Recruiting
• Phase: Phase 2
• Start date: May 8, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2023
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: 028-88610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Biological:
• CM338
CM338 injection

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

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