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NCT Number: NCT05775042

Clinical Study of CM338 in the Treatment of 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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Jicheng Lv

CONTACT

[email protected]

13161753111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM338

Biological

CM338 injection

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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