Back to resultsClinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
Primary Purpose
IgA Nephropathy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM338
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy
Eligibility 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.
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
CM338 will be injected subcutaneously.
CM338 will be injected subcutaneously.
CM338 will be injected subcutaneously.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05775042
Brief Title
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
Official Title
A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
In 1968, immunoglobulin A nephropathy (IgAN) was developed by French pathologist Dr. Jean Berger and his colleague Dr. Nicole Hinglais that what is described as glomerular "immunoglobulin A (IgA)-immune globule" - immune globule Protein G (IgG) intercapillary deposition" of kidney disease, the main pathological feature of which is on the glomerulus IgA deposition, usually accompanied by local cell proliferation and stromal dilation. Since there is not enough specificity and spirit Biomarkers of sensitivity, the only way to confirm the diagnosis is renal biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
CM338 will be injected subcutaneously.
Arm Title
Group B
Arm Type
Experimental
Arm Description
CM338 will be injected subcutaneously.
Arm Title
Group C
Arm Type
Experimental
Arm Description
CM338 will be injected subcutaneously.
Intervention Type
Biological
Intervention Name(s)
CM338
Intervention Description
CM338 injection
Primary Outcome Measure Information:
Title
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
Description
To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.
Time Frame
up to week 112
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Jia
Phone
028-88610620
Email
qianjia@keymedbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jicheng Lv
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jicheng Lv
Phone
13161753111
Email
jichenglv75@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
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