Active — Not RecruitingNot Applicable

The Clinical Application Study of Obinutuzumab in Pediatric Refractory Nephrotic Syndrome

China100 participantsStarted 2026-01-01

Plain-language summary

Primary nephrotic syndrome (PNS) in children is a clinical syndrome characterized by massive proteinuria, hypoalbuminemia, edema, and hyperlipidemia. The main subtypes include steroid-sensitive nephrotic syndrome (SSNS) and steroid-resistant nephrotic syndrome (SRNS), among which frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS) are relatively common in clinical practice. In recent years, anti-CD20 monoclonal antibodies, such as rituximab (RTX), have achieved remarkable efficacy in the treatment of pediatric NS, particularly in SDNS/FRNS and SRNS. However, a subset of children exhibit suboptimal responses to RTX or cannot continue its use due to allergic reactions. Obinutuzumab (OBI) is a novel fully humanized anti-CD20 monoclonal antibody. Compared with RTX, OBI exhibits higher affinity for B cells and can bind to distinct CD20 epitopes, demonstrating stronger anti-B cell activity in vitro. Therefore, OBI has emerged as a potential alternative for patients who are unresponsive or intolerant to RTX \[1\]. Currently, OBI is a next-generation glycoengineered humanized anti-CD20 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and apoptosis-inducing capabilities compared with RTX. Preliminary studies have shown its favorable efficacy and safety in adult systemic lupus erythematosus, refractory membranous nephropathy, transplant rejection, and pediatric SDNS/FRNS \[2-3\] and SRNS \[4-5\]. Clinical centers both domestically and internationally have already applied OBI in pediatric PNS patients who respond poorly to or are intolerant of RTX; however, no systematic studies have been conducted to date. As a leading pediatric nephrology center in western China, affiliated with the National Clinical Medical Center, our institution plans to use OBI in children with refractory PNS. The goal is to provide a safer and more effective B cell-targeted therapy, with an expected complete or partial remission in over 80% of patients. This approach aims to significantly reduce dependency on steroids, cyclosporine, tacrolimus, and other drugs, offering children with kidney disease a more precise and safer treatment pathway. This study will be the first in China to systematically evaluate the efficacy and safety of obinutuzumab in pediatric refractory PNS-including steroid resistance, frequently relapsing or steroid-dependent cases resistant to standard second-line therapy-and compare it with RTX to determine its ability to maintain disease remission and facilitate steroid withdrawal.

Who can participate

Age range

1 Year – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Diagnostic Criteria for Pediatric Primary Nephrotic Syndrome (PNS): Children aged 1 to 18 years who meet the following criteria: Edema: Prominent edema, typically gravitational, affecting the eyelids and lower limbs. Massive proteinuria: Defined as urine protein-to-creatinine ratio (UPCR) ≥ 200 mg/mmol or 24-hour urine protein ≥ 40 mg/m²·h. Hypoalbuminemia: Serum albumin commonly below 25 g/L. Hyperlipidemia: Such as elevated total cholesterol. Subtypes of Pediatric PNS: Steroid-sensitive nephrotic syndrome (SSNS) Steroid-resistant nephrotic syndrome (SRNS) SSNS can be further divided into steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS), with the following definitions: SSNS: An important clinical subtype of PNS. Diagnostic criteria: patients receiving standard-dose prednisone or prednisolone (usually 1.5-2.0 mg/kg/day or 60 mg/m²/day, maximum 60 mg/day) achieve urine protein remission within 4 weeks. SDNS: Initial response to glucocorticoid therapy is good, with proteinuria remission within 4 weeks. At least two relapses occur during steroid tapering or within 14 days after discontinuation, including relapses during dose reduction. FRNS: Occurrence of three or more relapses within 12 months, or two or more relapses within 6 months. A relapse is defined as consecutive 3-day morning urine protein ≥ +++ by dipstick or UPCR ≥ 200 mg/mmol. SRNS: Failure to achieve remission after 4 weeks of full-dose gluco…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the efficacy of obinutuzumab (OBI) in pediatric refractory nephrotic syndrome

Timeframe: 12 months

Trial details

NCT IDNCT07612592

SponsorChildren's Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Primary Nephrotic Syndrome trials