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NOT YET RECRUITING
NCT07888335
PHASE4

Efficacy and Safety of Obinutuzumab Beta in Primary IgA Nephropathy With Active Pathological Lesions

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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. 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. 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).

Official title: Efficacy and Safety of Obinutuzumab Beta in Primary IgA Nephropathy With Active Pathological Lesions: A Prospective, Open-Label, Exploratory Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-12-10

Completion Date

2028-12-30

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

Obinutuzumab Beta

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.

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China