Study of CM313 in Subject With IgA Nephropathy

Launched by KEYMED BIOSCIENCES CO.LTD · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM313 for people with a kidney condition known as IgA nephropathy. The goal of the study is to find out if CM313 is safe and effective in helping patients with this condition. The trial is designed to compare the effects of CM313 with a placebo, which is an inactive substance that looks like the treatment but doesn’t have any active ingredients. This study will include participants aged between 18 and 75 who have been diagnosed with IgA nephropathy and are currently stable on their prescribed kidney medications.

To be eligible for this trial, participants need to understand the study and agree to take part by signing a consent form. They should also have a recent kidney biopsy supporting their diagnosis and a certain level of kidney function. However, individuals with specific conditions like severe liver disease or a history of certain infections or cancers will not be able to participate. Those who join the study can expect regular check-ins to monitor their health and any changes from the treatment. It’s important to note that the trial is not yet recruiting participants, so interested individuals should stay tuned for updates on when they can apply.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to comprehend the research study and voluntarily signing the informed consent form (ICF).
• • 2. Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.
• • 3. Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening.
• • 4. Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor \[ACE-I\] or angiotensin receptor blocker \[ARB\]) for 12 weeks prior to screening.
• Exclusion Criteria:
• • 1. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
• • 2. Known or suspected hypersensitivity to excipients used in CM313.
• • 3. Rapidly progressive glomerulonephritis (RPGN), defined as a decrease of eGFR by more than 50% within 3 months prior to Baseline Visit and/or formation of crescents in more than 50% of glomeruli in renal paracentesis specimens.
• • 4. Confirmed acute kidney injury (AKI) within 4 weeks prior to Baseline Visit.
• • 5. Receipt of live attenuated vaccine within 30 days prior to the Baseline Visit or plan to receive such a vaccine during the study; receipt of novel coronavirus vaccines within 7 days prior to study drug administration.
• • 6. History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo transplantation during the study.
• • 7. History of severe recurrent or chronic infection.
• • 8. Current malignancy or history of malignancy during the previous 5 years, except adequately treated basal cell or squamous cell carcinomas of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix.