Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Recruiting now · Phase 2

Conditions studied: IgA Nephropathy

In brief

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.

Key facts

Study ID

NCT05775042

Run by

Keymed Biosciences Co.Ltd

People needed

70

Starts

2023-05-08

Expected to finish

2027-06-30

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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