NCT05775042RecruitingPhase 2
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 7 Mar 2023
- Start date
- 8 May 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- IgA nephropathy
- NCT number
- NCT05775042
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 8 May 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Major surgery is planned during the study.
Other illness
- May have active Mycobacterium tuberculosis infection.
Other
- Other reasons the investigator believes that the subject is not suitable to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.