Autoimmune DiseasesPhase 2NCT06513338
Complement C5 mAb in the Treatment of Anti-GBM Disease
A Phase 2 study testing Eculizumab in people with Autoimmune Diseases, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Eculizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 3 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Single Arm Phase II Trial of the Efficacy and Safety of Complement C5 Monoclonal Antibody in the Treatment of Anti-glomerular Basement Membrane Disease
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.
Read the 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 membrane within the kidney and/or the lung.Patients with anti-GBM disease typically present rapidly progressive glomerulonephritis, and often accompanied by lung hemorrhage. The hallmark of the disease is the linear deposition of IgG along the GBM on kidney biopsy. Complement activation is a pivotal step for kidney injuries during the development of human anti-GBM disease. Our previous study showed that the The levels of plasma SC5b-9 and urinary C5a were positively correlated with the serum creatinine at presentation and the percentage of crescents in glomeruli. Eculizumab is a recombinant humanized monoclonal antibody that specifically binds to a C5 terminal complement and inhibits the cleavage of C5 to C5a and C5b through complement activation. There are a few case reports showing therapeutic effects in anti-GBM disease. This trial will aim to evaluate the efficacy and safety of Eculizumab plus standard treatment in anti-GBM disease.
- Conditions
- Autoimmune Diseases
- Being tested
- Eculizumab
- Keywords
- complement C5, crescentic glomerulonephritis, anti-GBM disease, complement inhibition
- Medical subject headings
- Autoimmune Diseases, Anti-Glomerular Basement Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
eculizumab 900mg iv. per week for 4 weeks, then 1200mg every two weeks for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| eculizumab | Experimental | C5 monoclonal treatment plus standard treatment Receives: Drug: Eculizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney prognosis
ESKD (dialysis dependent) or kidney translation
Measured: 6 months after the first infusion of eculizumab
Secondary outcomes (4)
Changes in glomerular filtration rate (eGFR);
Change in level of estimated Glomerular Filtration Rate (eGFR) as measured by laboratory testing, reported in mL/min/1.73m².
Measured: from baseline to study completion, an average of 1 year
Changes in serum creatinine
Change in concentration of serum creatinine as measured by laboratory testing, reported in µmol/L
Measured: from baseline to study completion, an average of 1 year
Changes in blood urine nitrogen (BUN)
Change in concentration of Blood Urea Nitrogen (BUN) as measured by laboratory testing, reported in mmol/L
Measured: from baseline to study completion, an average of 1 year
side effects of eculizumab
The number of participants experiencing any adverse events determined by the investigator to be related to eculizumab treatment.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Mar 2024
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao CUI, Peking University First Hospital
- Investigators
- Zhao Cui, Principal investigator, PKUFH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513338
- Sponsor's protocol ID
- C5mAb in anti-GBM disease
- Status last verified
- Nov 2025
- First submitted
- 16 Jul 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Single Arm Phase II Trial of the Efficacy and Safety of Complement C5 Monoclonal Antibody in the Treatment of Anti-glomerular Basement Membrane Disease
- ClinicalTrials.gov ID
- NCT06513338
- Acronym / sponsor ID
- C5mAb in anti-GBM disease
- Conditions
- Autoimmune Diseases
- Keywords
- complement C5, crescentic glomerulonephritis, anti-GBM disease, complement inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 membrane within the kidney and/or the lung.Patients with anti-GBM disease typically present rapidly progressive glomerulonephritis, and often accompanied by lung hemorrhage. The hallmark of the disease is the linear deposition of IgG along the GBM on kidney biopsy. Complement activation is a pivotal step for kidney injuries during the development of human anti-GBM disease. Our previous study showed that the The levels of plasma SC5b-9 and urinary C5a were positively correlated with the serum creatinine at presentation and the percentage of crescents in glomeruli. Eculizumab is a recombinant humanized monoclonal antibody that specifically binds to a C5 terminal complement and inhibits the cleavage of C5 to C5a and C5b through complement activation. There are a few case reports showing therapeutic effects in anti-GBM disease. This trial will aim to evaluate the efficacy and safety of Eculizumab plus standard treatment in anti-GBM disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eculizumab | Experimental | Drug: EculizumabC5 monoclonal treatment plus standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eculizumabeculizumab 900mg iv. per week for 4 weeks, then 1200mg every two weeks for 8 weeks | Drug | eculizumab |
Primary outcome
kidney prognosis
Time frame: 6 months after the first infusion of eculizumab
ESKD (dialysis dependent) or kidney translation
4 secondary outcomes
Changes in glomerular filtration rate (eGFR);
Time frame: from baseline to study completion, an average of 1 year
Changes in serum creatinine
Time frame: from baseline to study completion, an average of 1 year
Changes in blood urine nitrogen (BUN)
Time frame: from baseline to study completion, an average of 1 year
side effects of eculizumab
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Cui principal investigator
PKUFH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eculizumab in people with Autoimmune Diseases, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kidney prognosis (time frame: 6 months after the first infusion of eculizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.