CompletedPhase 2

Complement C5 mAb in the Treatment of Anti-GBM Disease

China16 participantsStarted 2024-03-01

Plain-language 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 disease. Complement has been shown to participate in the pathogenesis of anti-GBM disease. This study aims to the investigate the therapeutic effects and safety of C5 monoclonal antibody in the treatment of anti-GBM disease.

Who can participate

Age range18 Years

SexALL

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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;

What they're measuring

kidney prognosis

Timeframe: 6 months after the first infusion of eculizumab

Trial details

NCT IDNCT06513338

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-03

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