Treatment of IgA Nephropathy with CM338
A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
This study is testing a new treatment called CM338 to see if it can help people with IgA nephropathy manage their kidney disease better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05775042 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized phase II clinical study evaluates the efficacy and safety of CM338 in patients with Immunoglobulin A nephropathy (IgAN). The study will also observe pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of the treatment. Participants will be monitored for their response to the drug, and the study aims to provide insights into the management of this kidney disease.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-75 who understand the study and can provide informed consent.
Not a fit: Patients with a history of HIV infection or those with active tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from IgA nephropathy.
How similar studies have performed: While there have been studies on IgA nephropathy, the specific approach with CM338 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jicheng Lv — Peking University First Hospital
- Study coordinator: Qian Jia
- Email: qianjia@keymedbio.com
- Phone: 028-88610620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.