Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Launched by KEYMED BIOSCIENCES CO.LTD · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM338 for people with Immunoglobulin A (IgA) nephropathy, a kidney condition that can affect how well your kidneys work. The goal of the study is to see how effective and safe this treatment is, as well as to understand how the body processes the medication and how it affects the immune system. The study is currently looking for participants aged 18 to 75 who can provide informed consent and are willing to use contraception during the study.

If you decide to participate, you will be randomly assigned to receive either CM338 or a placebo (a treatment that looks the same but has no active ingredients) to compare the results. Throughout the study, your health will be closely monitored, and you may have some tests or visits to the study site. It’s important to note that if you have certain medical conditions, such as a recent history of HIV or tuberculosis, or if you've had major surgery planned, you may not be eligible to participate. This trial could help improve treatments for those with IgA nephropathy in the future.

Gender

ALL

Eligibility criteria

• 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.