Anti-Glomerular Basement Membrane DiseasePhase 2NCT06607016
A Clinical Trial With KJ103 in Anti-GBM Disease
A Phase 2 study testing KJ103 for Injection, Cyclophosphamide and Glucocorticoids in people with Anti-Glomerular Basement Membrane Disease, run by Shanghai Bao Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Glomerular Basement Membrane Disease
- What is being tested?
- KJ103 for Injection, Cyclophosphamide and Glucocorticoids
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients aged ≥18 years, both sexes.
- Diagnosed with anti-GBM disease. Positive anti-GBM antibodies at screening, with or without ANCA antibody positivity.
- With or without symptoms of haematuria and proteinuria.
- Patients of childbearing potential who do not plan to have children during the study and for 6 months after the end of the study, or who are using effective contraception during sexual intercourse.
Who cannot join
- Anuria for more than 24 hours prior to the first dose.
- Diagnosis of anti-GBM disease more than 14 days prior to first dose.
- Moderate to severe pulmonary haemorrhage requiring mechanical ventilation during the screening period, including those occurring within two weeks prior to signing the informed consent form.
- Severe renal disease not caused by anti-GBM disease, such as lupus nephritis, which, in the opinion of the investigator, makes them unsuitable for participation in this study.
- Pregnant or breastfeeding at the time of screening.
- Have a serious underlying medical condition other than anti-GBM disease, such as infection, autoimmune disease, respiratory disease, cardiovascular disease, central nervous system disease, etc., that the investigator deems unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100000
About this study
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
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.
Read the detailed description
Anti-glomerular basement membrane (GBM) disease is a severe, rare autoimmune disorder with an internationally reported incidence of 0.5-1/1 million. It is defined as a vasculitis in which anti-GBM antibodies affect glomerular capillaries, pulmonary capillaries or both. Pulmonary involvement leads to pulmonary haemorrhage and renal involvement can lead to glomerulonephritis with necrosis and crescents.
Anti-GBM disease is a severe autoimmune disorder characterised by rapidly progressive glomerulonephritis and positive anti-GBM antibodies. Antibodies can be found in the circulation and deposited in the lungs and kidneys, mediating renal injury through complement activation and recruitment of inflammatory cells. If left untreated, the vast majority of patients will progress to end-stage renal disease (ESRD) or die from pulmonary haemorrhage. Early detection and measures to reduce anti-GBM antibody levels have the potential to alter prognosis and protect renal function. Unfortunately, many patients with anti-GBM disease are diagnosed late and renal function is not restored even with an aggressive treatment regimen of plasma exchange (PE) combined with immunosuppression. Current KDIGO (Kidney Disease Improving Global Prognosis Organisation) guidelines state that the clinical treatment of anti-GBM disease is a combination of glucocorticoids, cyclophosphamide and PE. Despite treatment, patients continue to produce anti-GBM antibodies in their bodies. Rebound anti-GBM antibodies are usually indicative of adverse renal outcomes and PE must be initiated to remove the rebound antibodies.PE is an effective means of removing circulating anti-GBM antibodies, but only removes about 1/3 of the percentage per treatment, so multiple treatments are required to achieve complete removal.
This is a single-arm Phase II study designed to evaluate the preliminary efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease. The trial is expected to enrol 9 to 12 subjects who will receive KJ103 treatment.
- Being tested
- KJ103 for Injection, Cyclophosphamide, Glucocorticoids, Plasma exchange (PE)
- Medical subject headings
- Anti-Glomerular Basement Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KJ103 for InjectionDrug
Subjects will administered KJ103 intravenously on D1 and adjunctively on D8
CyclophosphamideDrug
Hence treatment prevents formation of new anti-GBM antibodies.
GlucocorticoidsDrug
Glucocorticoids inhibit the inflammation process.
Plasma exchange (PE)Procedure or surgery
PLEX removes the patient\'s pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | KJ103 +SOC(SoC consists of a standardized combination of PE, Cyclophosphamide, and glucocorticoids) Receives: Drug: KJ103 for Injection; Drug: Cyclophosphamide; Drug: Glucocorticoids; Procedure: Plasma exchange (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Proportion of subjects with renal function after KJ103 administration.
Measured: day 90, day 180
Secondary outcomes (12)
Adverse events
Assessing the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) via the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: day 180
Proportion and number of subjects requiring PE
Proportion and number of subjects requiring PE after KJ103 administration.
Measured: day 180
Anti-GBM antibodies
Number of days positive for anti-GBM antibodies after KJ103 administration.
Measured: day 180
Immunogenicity
Immunogenicity of KJ103 (Anti-KJ103 antibody) in patients with anti-GBM disease.
Measured: day 180
eGFR and change from baseline.
Estimated glomerular filtration rate (eGFR). Glomerular filtration rate is an estimate of the amount of ultrafiltrate produced by each side of the kidney per unit of time and is an indicator of kidney function.
Measured: Day28, Day60, Day90, Day120, Day150, Day180
Pharmacokinetics of KJ103 (Cmax)
Maximum observed serum concentration of KJ103 following dosing (Cmax)
Measured: day 7
Pharmacokinetics of KJ103 (AUC)
Area under the serum concentration versustime curve (AUC)
Measured: day 7
Pharmacokinetics of KJ103 (t1/2)
Half-life of KJ103
Measured: day 7
Pharmacokinetics of KJ103 (CL)
Clearance(CL) is a measure of the ability of the body to clear KJ103
Measured: day 7
Pharmacokinetics of KJ103 (Vz)
Vz = Volume of distribution during the elimination phase
Measured: day 7
Pharmacodynamic profile (Serum IgG levels)
Serum IgG levels after KJ103 dosing
Measured: day 180
Pharmacodynamics-Anti neutrophil cytoplasmic antibodies (ANCA)
Serum Anti neutrophil cytoplasmic antibodies (ANCA) levels after KJ103 dosing
Measured: day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Glomerular Basement Membrane DiseaseStudies of the same condition, open and under way.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607016
- Sponsor's protocol ID
- SHBJ-KJ103-002
- Status last verified
- Jun 2025
- First submitted
- 17 Sep 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06607016
- Acronym / sponsor ID
- SHBJ-KJ103-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 23 Sep 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.
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.
Detailed description
Anti-glomerular basement membrane (GBM) disease is a severe, rare autoimmune disorder with an internationally reported incidence of 0.5-1/1 million. It is defined as a vasculitis in which anti-GBM antibodies affect glomerular capillaries, pulmonary capillaries or both. Pulmonary involvement leads to pulmonary haemorrhage and renal involvement can lead to glomerulonephritis with necrosis and crescents.
Anti-GBM disease is a severe autoimmune disorder characterised by rapidly progressive glomerulonephritis and positive anti-GBM antibodies. Antibodies can be found in the circulation and deposited in the lungs and kidneys, mediating renal injury through complement activation and recruitment of inflammatory cells. If left untreated, the vast majority of patients will progress to end-stage renal disease (ESRD) or die from pulmonary haemorrhage. Early detection and measures to reduce anti-GBM antibody levels have the potential to alter prognosis and protect renal function. Unfortunately, many patients with anti-GBM disease are diagnosed late and renal function is not restored even with an aggressive treatment regimen of plasma exchange (PE) combined with immunosuppression. Current KDIGO (Kidney Disease Improving Global Prognosis Organisation) guidelines state that the clinical treatment of anti-GBM disease is a combination of glucocorticoids, cyclophosphamide and PE. Despite treatment, patients continue to produce anti-GBM antibodies in their bodies. Rebound anti-GBM antibodies are usually indicative of adverse renal outcomes and PE must be initiated to remove the rebound antibodies.PE is an effective means of removing circulating anti-GBM antibodies, but only removes about 1/3 of the percentage per treatment, so multiple treatments are required to achieve complete removal.
This is a single-arm Phase II study designed to evaluate the preliminary efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease. The trial is expected to enrol 9 to 12 subjects who will receive KJ103 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: KJ103 for Injection, Drug: Cyclophosphamide, Drug: Glucocorticoids, Procedure: Plasma exchange (PE)KJ103 +SOC(SoC consists of a standardized combination of PE, Cyclophosphamide, and glucocorticoids) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years, both sexes.
- Diagnosed with anti-GBM disease. Positive anti-GBM antibodies at screening, with or without ANCA antibody positivity.
- With or without symptoms of haematuria and proteinuria.
- Patients of childbearing potential who do not plan to have children during the study and for 6 months after the end of the study, or who are using effective contraception during sexual intercourse.
Key exclusion criteria (6 listed)
- Anuria for more than 24 hours prior to the first dose.
- Diagnosis of anti-GBM disease more than 14 days prior to first dose.
- Moderate to severe pulmonary haemorrhage requiring mechanical ventilation during the screening period, including those occurring within two weeks prior to signing the informed consent form.
- Severe renal disease not caused by anti-GBM disease, such as lupus nephritis, which, in the opinion of the investigator, makes them unsuitable for participation in this study.
- Pregnant or breastfeeding at the time of 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 |
|---|---|---|
| KJ103 for InjectionSubjects will administered KJ103 intravenously on D1 and adjunctively on D8 | Drug | Experimental Group |
| CyclophosphamideHence treatment prevents formation of new anti-GBM antibodies. | Drug | Experimental Group |
| GlucocorticoidsGlucocorticoids inhibit the inflammation process. | Drug | Experimental Group |
| Plasma exchange (PE)PLEX removes the patient\'s pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid. | Procedure or surgery | Experimental Group |
Primary outcome
Renal function
Time frame: day 90, day 180
Proportion of subjects with renal function after KJ103 administration.
12 secondary outcomes
Adverse events
Time frame: day 180
Proportion and number of subjects requiring PE
Time frame: day 180
Anti-GBM antibodies
Time frame: day 180
Immunogenicity
Time frame: day 180
eGFR and change from baseline.
Time frame: Day28, Day60, Day90, Day120, Day150, Day180
Pharmacokinetics of KJ103 (Cmax)
Time frame: day 7
Pharmacokinetics of KJ103 (AUC)
Time frame: day 7
Pharmacokinetics of KJ103 (t1/2)
Time frame: day 7
Pharmacokinetics of KJ103 (CL)
Time frame: day 7
Pharmacokinetics of KJ103 (Vz)
Time frame: day 7
Pharmacodynamic profile (Serum IgG levels)
Time frame: day 180
Pharmacodynamics-Anti neutrophil cytoplasmic antibodies (ANCA)
Time frame: day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 KJ103 for Injection, Cyclophosphamide and Glucocorticoids in people with Anti-Glomerular Basement Membrane Disease, run by Shanghai Bao Pharmaceuticals Co., Ltd. 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Renal function (time frame: day 90, day 180). 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 13 Jun 2025.