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A Clinical Trial With KJ103 in Anti-GBM Disease
Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.
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.
Official title: An Open-Label, Single-Arm Phase II Clinical Trial to Evaluate the Initial Efficacy, Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of KJ103 for the Treatment of Patients With Anti-Glomerular Basement Membrane Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-10-21
Completion Date
2026-03
Last Updated
2025-06-13
Healthy Volunteers
No
Interventions
KJ103 for Injection
Subjects will administered KJ103 intravenously on D1 and adjunctively on D8
Cyclophosphamide
Hence treatment prevents formation of new anti-GBM antibodies.
Glucocorticoids
Glucocorticoids inhibit the inflammation process.
Plasma exchange (PE)
PLEX removes the patient\'s pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid.
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China