Status:
ACTIVE_NOT_RECRUITING
A Clinical Trial With KJ103 in Anti-GBM Disease
Lead Sponsor:
Shanghai Bao Pharmaceuticals Co., Ltd.
Conditions:
Anti-Glomerular Basement Membrane Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An open-label, single-arm Phase II study to evaluate the preliminary efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease.
Detailed Description
Anti-glomerular basement membrane (GBM) disease is a severe, rare autoimmune disorder with an internationally reported incidence of 0.5-1/1 million. It is defined as a vasculitis in which anti-GBM ant...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients aged ≥18 years, both sexes.
- Diagnosed with anti-GBM disease. Positive anti-GBM antibodies at screening, with or without ANCA antibody positivity.
- With or without symptoms of haematuria and proteinuria.
- Patients of childbearing potential who do not plan to have children during the study and for 6 months after the end of the study, or who are using effective contraception during sexual intercourse.
- Exclusion criteria:
- Anuria for more than 24 hours prior to the first dose.
- Diagnosis of anti-GBM disease more than 14 days prior to first dose.
- Moderate to severe pulmonary haemorrhage requiring mechanical ventilation during the screening period, including those occurring within two weeks prior to signing the informed consent form.
- Severe renal disease not caused by anti-GBM disease, such as lupus nephritis, which, in the opinion of the investigator, makes them unsuitable for participation in this study.
- Pregnant or breastfeeding at the time of screening.
- Have a serious underlying medical condition other than anti-GBM disease, such as infection, autoimmune disease, respiratory disease, cardiovascular disease, central nervous system disease, etc., that the investigator deems unsuitable for participation in this trial.
Exclusion
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06607016
Start Date
October 21 2024
End Date
March 1 2026
Last Update
June 13 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000