Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

October 14, 2024 updated by: Keymed Biosciences Co.Ltd

A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
Time Frame: 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.
up to week 112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Jicheng Lv, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM338-105101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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