Status:
COMPLETED
Complement C5 mAb in the Treatment of Anti-GBM Disease
Lead Sponsor:
Peking University First Hospital
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Anti-GBM disease is the most severe form of glomerulonephritis. Despite of the standard treatment including plasmapheresis and immunosuppressant, 70% of the patients still go into end-stage kidney dis...
Detailed Description
Anti-glomerular basement membrane (anti-GBM) disease is the most severe form of autoimmune glomerulonephritis, characterized by the production of autoantibodies targeting the components of basement me...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Positive circulating anti-GBM antibody, with proteinuria or hematuria or any clinical signs of kidney injuries.
- And or kidney biopsy showed typical IgG linear deposition along the GBM
- At least 18 years old
- Exclusion Criteria
- Allergic to eculizumab, mouse protein or the investigational drug and any of its excipients;
- Uncontrolled meningococcal infection,or those who have not received meningitis prophylactic antibiotic treatment or meningitis vaccination;
- Diagnosis of anti-GBM disease for more than 12 weeks before signing the informed consent form;
- Pregnant or lactating
- Received investigational drug within 30 days or 4 half-lives (whichever is longer) prior to screening;
- Other serious poorly controlled comorbid diseases that affect the compliance of the trial protocol or the interpretation of results within 3 months prior to screening, including cardiovascular and cerebrovascular diseases, lung disease, etc.;
- Presence of any medical history or disease that, in the opinion of the investigator, may expose the patient's participation in the study to an unacceptable risk;
Exclusion
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06513338
Start Date
March 1 2024
End Date
November 3 2025
Last Update
December 5 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, China, 100038