Non-immunosuppressive treatment for IgA nephropathy.
David J Tunnicliffe, Sharon Reid, Jonathan C Craig...
https://pubmed.ncbi.nlm.nih.gov/38299639Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID05775042
A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
Led by Keymed Biosciences Co.Ltd · Updated on 2024-10-15
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of CM338 in adults with Immunoglobulin A (IgA) nephropathy, a kidney disease characterized by abnormal IgA deposits in the glomerulus. This randomized, multicenter Phase II clinical trial aims to evaluate the safety and effectiveness of CM338, while also monitoring how the drug behaves in the body, its biological effects, and the immune response it might trigger. The study is sponsored by Keymed Biosciences Co. Ltd. Participants will receive CM338 injections under the skin. The study includes multiple experimental groups, all receiving CM338 via subcutaneous injections. The trial will last up to 112 weeks, during which the participants' reactions to the treatment and any side effects will be closely observed. During the study, participants will undergo regular assessments to monitor safety and treatment effects. Researchers will track adverse events related to CM338 and collect data on pharmacokinetics and pharmacodynamics. Participants must take effective contraception during the study. The total duration of participation is up to 112 weeks, including follow-ups to ensure ongoing safety and gather comprehensive data.
CONDITIONS
Brief Title
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Understand the study and voluntarily sign the informed consent form
- Agree to use effective contraception throughout the study period
You will not qualify if you...
- Used other investigational drugs within 30 days before the first study dose
- History of HIV infection
- Tested positive for Treponema pallidum antibody during screening
- Possible active Mycobacterium tuberculosis infection
- Planned major surgery during the study
- Any other condition that the investigator considers unsuitable for participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 112 weeks
Participants receive CM338 injections subcutaneously as part of the treatment for Immunoglobulin A Nephropathy.
Visit schedule details not specified
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
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Research Team
Q
Qian Jia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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