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Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Sponsor
Keymed Biosciences Co.Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05775042
Collaborator
(none)
70
Enrollment
3
Arms
48
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CM338
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

CM338 will be injected subcutaneously.

Biological: CM338
CM338 injection
Experimental: Group B

CM338 will be injected subcutaneously.

Biological: CM338
CM338 injection
Experimental: Group C

CM338 will be injected subcutaneously.

Biological: CM338
CM338 injection

Outcome Measures

Primary Outcome Measures

  1. The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy [up to week 112]

    To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female aged 18-75.

  • Understand the nature of research 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 researcher believes that the subject is not suitable to participate in this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier:
NCT05775042
Other Study ID Numbers:
  • CM338-105101
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA

Study Results

No Results Posted as of Mar 20, 2023