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
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
October 15, 2024
October 1, 2024
4.1 years
March 7, 2023
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.
up to week 112
Study Arms (3)
Group A
EXPERIMENTALCM338 will be injected subcutaneously.
Group B
EXPERIMENTALCM338 will be injected subcutaneously.
Group C
EXPERIMENTALCM338 will be injected subcutaneously.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, China
Related Publications (1)
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PMID: 38299639DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jicheng Lv
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 20, 2023
Study Start
May 8, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
October 15, 2024
Record last verified: 2024-10