Primary IgA NephropathyPhase 4NCT07888335
Efficacy and Safety of Obinutuzumab Beta in Primary IgA Nephropathy With Active Pathological Lesions
A Phase 4 study testing Obinutuzumab Beta in people with Primary IgA Nephropathy, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate if obinutuzumab beta works to treat primary IgA nephropathy with active proliferative lesions in adults. It will also learn about the safety of obinutuzumab beta. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary IgA Nephropathy
- What is being tested?
- Obinutuzumab Beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2026to 30 Dec 2028
- Phase
- Phase 4
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Willing to participate, able to complete treatment, follow-up, and related examinations, and able to provide written informed consent.
- 2. Age 18 to 70 years, inclusive; male or female.
- 3. Primary IgA nephropathy confirmed by kidney biopsy within 6 months before enrollment, with at least one of the following pathological features: E1: endocapillary hypercellularity; C1 or C2: cellular or fibrocellular crescents (C1: at least 1 glomerulus with crescents and involved glomeruli ≤25%; C2: >25% glomeruli with crescents); Fibrinoid necrosis of capillary loops in at least one glomerulus.
- 4. Received stable optimized supportive care for at least 12 weeks before screening, including maximum allowed or maximum tolerated dose of ACEi or ARB. For participants with contraindications or intolerance to ACEi/ARB, the reason must be documented. SGLT2i or MRA may be used according to clinical indications if the dose has been stable for at least 12 weeks before screening. Background therapy should generally remain stable during the study, except for adjustments for safety or clinical needs.
- 5. Two 24-hour urinary protein measurements during screening both ≥1.0 g/day, at least 7 days apart, with persistent microscopic hematuria (>3 red blood cells per high-power field).
- 6. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² at screening, calculated using the CKD-EPI formula.
Who cannot join
- 1. Systemic diseases that may cause IgA deposition in the renal mesangium, including but not limited to IgA vasculitis, ankylosing spondylitis, and systemic lupus erythematosus.
- 2. Kidney biopsy showing any of the following: Tubular atrophy or interstitial fibrosis >50% (Oxford T2); Crescents in >50% of glomeruli, or clinical presentation suggesting rapidly progressive glomerulonephritis (e.g., rapid eGFR decline with massive proteinuria/hematuria);
- ≥50% globally sclerotic glomeruli; Isolated S1 without podocytopathy features (e.g., podocyte hypertrophy/tip lesion).
- 3. Other glomerular diseases (e.g., C3 glomerulopathy, diabetic nephropathy, membranous nephropathy).
- 4. Prior kidney transplantation.
- 5. Within 12 weeks before screening, received any of the following: Systemic glucocorticoids (prednisone or equivalent, including budesonide enteric-coated capsules) >10 mg/day for >14 consecutive days; Immunosuppressants/modulators (e.g., mycophenolate, cyclosporine, calcineurin inhibitors, cyclophosphamide, azathioprine, leflunomide, hydroxychloroquine); Chinese patent medicines with immunosuppressive effects (e.g., Tripterygium or Qingteng preparations); Or anticipated need for any of the above therapies during the study as assessed by the investigator.
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- 6. Within 6 months before study treatment, received biologics such as CD20 monoclonal antibodies, CD38 monoclonal antibodies, APRIL monoclonal antibodies (e.g., sibeprenlimab), BAFF/APRIL fusion proteins, cytokine inhibitors, or complement pathway drugs.
- 7. Any cardiovascular or cerebrovascular event within 6 months: myocardial infarction, unstable angina, ventricular arrhythmia, NYHA class III or IV congestive heart failure, stroke, etc.
- 8. Active infection or high-risk latent infection
- 9. Poorly controlled blood pressure at screening: systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg (excluding hemodynamic fluctuation-induced proteinuria elevation).
- 10. Malignancy diagnosed within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- 11. Breastfeeding or pregnant women, or men and women of childbearing potential unwilling to use adequate contraception during the study.
- 12. Known allergy to any component of obinutuzumab beta.
- 13. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
About this study
Official title: Efficacy and Safety of Obinutuzumab Beta in Primary IgA Nephropathy With Active Pathological Lesions: A Prospective, Open-Label, Exploratory Study
The goal of this clinical trial is to evaluate if obinutuzumab beta works to treat primary IgA nephropathy with active proliferative lesions in adults. It will also learn about the safety of obinutuzumab beta. The main questions it aims to answer are:
Does obinutuzumab beta reduce 24-hour urinary protein at Week 24 compared with baseline? Does obinutuzumab beta improve kidney function, reduce hematuria, and lower Gd-IgA1 levels? Does obinutuzumab beta change active lesionson repeat kidney biopsy at Week 52? Researchers will also look at B-cell depletion, disease relapse, and the proportion of participants achieving proteinuria <0.5 g/d.
Read more
Participants will:
Receive obinutuzumab beta 1000 mg by intravenous infusion 4 times: at Week 0, Week 2, Week 24, and Week 26.
Continue their usual supportive kidney care (maximum tolerated ACEi or ARB, with or without stable SGLT2i or MRA).
Visit the clinic at Weeks 0, 2, 12, 24, 26, 36, and 52 (8 visits including screening).
- Conditions
- Primary IgA Nephropathy
- Being tested
- Obinutuzumab Beta
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obinutuzumab BetaDrug
In this single-arm, open-label, exploratory study, all participants receive Obinutuzumab Beta 1000 mg by intravenous infusion on W0D1, W2D15, W24D169, and W26D183 (4 doses total). The first dose is given with premedication: dexamethasone 20 mg (or methylprednisolone 80 mg) 1 hour before infusion, and acetaminophen 650-1000 mg plus diphenhydramine 40 mg 30 minutes before infusion. The initial infusion rate is 25 mg/hr, increased to 50 mg/hr after 30 minutes if tolerated, then by 50 mg/hr every 30 minutes up to a maximum of 400 mg/hr. For subsequent infusions, the starting rate and escalation follow the protocol based on prior infusion-related reactions. All participants continue stable optimized background supportive care (maximum tolerated/allowed ACEi or ARB, with or without stable SGLT2i/MRA). No placebo or active comparator is used.
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab Beta 1000 mg Intravenous Infusion | Experimental | Not described Receives: Drug: Obinutuzumab Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in 24-hour urinary protein from baseline at Week 24
Measured: Baseline, Week 24
Secondary outcomes (5)
Change in 24-hour urinary protein/UPCR from baseline at Weeks 12, 36, and 52
Measured: Baseline, Weeks 12, 36, 52
Change in eGFR from baseline at Weeks 12, 24, 36, and 52
Measured: Baseline, Weeks 12, 24, 36, 52
Proportion of patients with 24-hour urinary protein <0.5 g/d at Weeks 12, 24, 36, and 52
Measured: Baseline, Weeks 12, 24, 36, 52
Change in Gd-IgA1 levels from baseline at Weeks 12, 24, 36, and 52
Measured: Baseline, Weeks 12, 24, 36, 52
Proportion of patients with disease relapse up to Week 52
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start10 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Ruijin 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888335
- Sponsor's protocol ID
- MIL62-IIT-2026-A03
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No