ANCA-Associated Glomerulonephritis (AAGN)Phase 2NCT07746180
Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
A Phase 2 study testing Obinutuzumab beta and Glucocorticoids in people with ANCA-Associated Glomerulonephritis (AAGN) and ANCA-Associated Vasculitis (AAV), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV)
- What is being tested?
- Obinutuzumab beta and Glucocorticoids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2026to 30 Mar 2029
- 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
- New diagnosis of ANCA-associated vasculitis (Granulomatosis with polyangiitis [GPA] or Microscopic polyangiitis [MPA]) according to the Chapel Hill Consensus Conference definitions.
- Positive for PR3-ANCA or MPO-ANCA.
- Active renal involvement indicated by recent renal biopsy (pauci-immune necrotizing and/or crescentic glomerulonephritis) OR active urine sediment characterized by glomerular hematuria and proteinuria.
- Provided signed informed consent.
Who cannot join
- Prior treatment with targeted B-cell therapies (e.g., Rituximab) or standard cyclophosphamide, azathioprine, or mycophenolate mofetil for AAV.
- Current requirement for dialysis, or history of dialysis.
- Presence of life-threatening acute vasculitis manifestations other than renal involvement (e.g., diffuse alveolar hemorrhage, respiratory failure, bowel perforation, cerebral vasculitis).
- History of malignancy within the past 5 years.
- Coexisting multisystem autoimmune diseases (e.g., systemic lupus erythematosus, anti-GBM disease).
- Active severe infections, active tuberculosis, or chronic viral infections (HBV with positive HBsAg or HBV-DNA, active HCV, HIV).
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis: A Prospective Exploratory Study
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).
Read the detailed description
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN). The primary objective is to assess the complete remission rate at Week 24.
- Being tested
- Obinutuzumab beta, Glucocorticoids
- Keywords
- ANCA-Associated Glomerulonephritis (AAGN), Obinutuzumab beta, Glucocorticoid
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obinutuzumab betaDrug
Also called MIL62
Intravenous infusion of Obinutuzumab beta administered during the induction phase.
GlucocorticoidsDrug
Oral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24.
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab beta + Glucocorticoid | Experimental | Participants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24. Receives: Drug: Obinutuzumab beta; Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) rate
Proportion of participants achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and complete withdrawal of oral glucocorticoids
Measured: Month 6 (Week 24)
Secondary outcomes (8)
Renal Remission (RR) rate
Proportion of participants achieving renal remission, defined by stabilization or improvement in renal function and resolution of active urinary sediment.
Measured: Up to Month 12
Change in estimated Glomerular Filtration Rate (eGFR)
Dynamic change of eGFR from baseline.
Measured: Up to Month 12
Change in proteinuria
Dynamic change of 24-hour urine protein or Urine Protein-to-Creatinine Ratio (UPCR) from baseline.
Measured: Up to Month 12
Incidence of End-Stage Renal Disease (ESRD) or death
Proportion of participants reaching the composite endpoint of ESRD or all-cause mortality.
Measured: Up to Month 12
Overall Remission rate
Proportion of participants achieving a BVAS of 0.
Measured: Up to Month 12
Proportion of participants achieving peripheral B-cell depletion
Pharmacodynamic assessment of peripheral B-cell count changes from baseline.
Measured: Up to Month 12
Change in ANCA serological status and titer levels
Proportion of participants achieving ANCA negativity and changes in ANCA titers from baseline.
Measured: Up to Month 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability evaluated by the number and severity of AEs graded according to CTCAE v6.0.
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start21 Aug 2026
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-Associated Glomerulonephritis (AAGN)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhe Feng, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746180
- Sponsor's protocol ID
- S2026-448-02
- Other IDs
- S2026-448-02
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis: A Prospective Exploratory Study
- ClinicalTrials.gov ID
- NCT07746180
- Acronym / sponsor ID
- S2026-448-02
- Keywords
- ANCA-Associated Glomerulonephritis (AAGN), Obinutuzumab beta, Glucocorticoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).
Detailed description
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN). The primary objective is to assess the complete remission rate at Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab beta + Glucocorticoid | Experimental | Drug: Obinutuzumab beta, Drug: GlucocorticoidsParticipants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- New diagnosis of ANCA-associated vasculitis (Granulomatosis with polyangiitis [GPA] or Microscopic polyangiitis [MPA]) according to the Chapel Hill Consensus Conference definitions.
- Positive for PR3-ANCA or MPO-ANCA.
- Active renal involvement indicated by recent renal biopsy (pauci-immune necrotizing and/or crescentic glomerulonephritis) OR active urine sediment characterized by glomerular hematuria and proteinuria.
- Provided signed informed consent.
Key exclusion criteria (7 listed)
- Prior treatment with targeted B-cell therapies (e.g., Rituximab) or standard cyclophosphamide, azathioprine, or mycophenolate mofetil for AAV.
- Current requirement for dialysis, or history of dialysis.
- Presence of life-threatening acute vasculitis manifestations other than renal involvement (e.g., diffuse alveolar hemorrhage, respiratory failure, bowel perforation, cerebral vasculitis).
- History of malignancy within the past 5 years.
- Coexisting multisystem autoimmune diseases (e.g., systemic lupus erythematosus, anti-GBM disease).
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 |
|---|---|---|
| Obinutuzumab betaAlso: MIL62Intravenous infusion of Obinutuzumab beta administered during the induction phase. | Drug | Obinutuzumab beta + Glucocorticoid |
| GlucocorticoidsOral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24. | Drug | Obinutuzumab beta + Glucocorticoid |
Primary outcome
Complete Remission (CR) rate
Time frame: Month 6 (Week 24)
Proportion of participants achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and complete withdrawal of oral glucocorticoids
8 secondary outcomes
Renal Remission (RR) rate
Time frame: Up to Month 12
Change in estimated Glomerular Filtration Rate (eGFR)
Time frame: Up to Month 12
Change in proteinuria
Time frame: Up to Month 12
Incidence of End-Stage Renal Disease (ESRD) or death
Time frame: Up to Month 12
Overall Remission rate
Time frame: Up to Month 12
Proportion of participants achieving peripheral B-cell depletion
Time frame: Up to Month 12
Change in ANCA serological status and titer levels
Time frame: Up to Month 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Month 12
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 Obinutuzumab beta and Glucocorticoids in people with ANCA-Associated Glomerulonephritis (AAGN) and ANCA-Associated Vasculitis (AAV), run by Chinese PLA General 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 4 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
Contact Zhe Feng (+86 010-66935462, zhezhe_4025@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (CR) rate (time frame: Month 6 (Week 24)). 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 15 Sep 2026.