Complement C5 mAb in the Treatment of Anti-GBM Disease

NCT06513338 | Completed Phase 2

• 1 other identifier: C5mAb in anti-GBM disease
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Autoimmune Diseases

Keywords

complement C5; crescentic glomerulonephritis; anti-GBM disease; complement inhibition

Outcome Measures

Primary Outcomes (1)

• kidney prognosis

  ESKD (dialysis dependent) or kidney translation

  6 months after the first infusion of eculizumab

Secondary Outcomes (4)

• Changes in glomerular filtration rate (eGFR);

  from baseline to study completion, an average of 1 year

• Changes in serum creatinine

  from baseline to study completion, an average of 1 year

• Changes in blood urine nitrogen (BUN)

  from baseline to study completion, an average of 1 year

• side effects of eculizumab

  at 6 months

Other Outcomes (1)

• kidney function recovery

  6 months after the first eculizumab infusion

Study Arms (1)

eculizumab

EXPERIMENTAL

C5 monoclonal treatment plus standard treatment

Drug: Eculizumab

Interventions

Eculizumab DRUG

eculizumab 900mg iv. per week for 4 weeks, then 1200mg every two weeks for 8 weeks

eculizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, 100038, China

Location

MeSH Terms

Conditions

Autoimmune Diseases; Anti-Glomerular Basement Membrane Disease

Interventions

eculizumab

Condition Hierarchy (Ancestors)

Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Zhao Cui

  PKUFH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: March 1, 2024
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)