New hope for kids with tough kidney disease: obinutuzumab may replace steroids
NCT ID NCT07612592
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called obinutuzumab in 100 children aged 1-18 with refractory nephrotic syndrome, a kidney condition causing swelling and protein loss. The drug targets immune cells to reduce disease flares and dependence on steroids and other medications. Researchers aim to see if it works better than an older similar drug (rituximab) and helps more children achieve remission.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pediatric Primary Nephrotic Syndrome
- Ages
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1 year to 18 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 glucocorticoid therapy (prednisone or prednisolone 60 mg/m²/day or 1.5-2 mg/kg/day, maximum 60 mg/day) following PNS diagnosis, with persistent proteinuria (consecutive 3-day urine protein ≥ +++ by dipstick or UPCR ≥ 200 mg/mmol). \- Exclusion Criteria: * Secondary PNS: Chronic kidney disease caused by underlying conditions such as Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis B, diabetes, hereditary nephritis, severe infections, tumors, or medications. Exclusion criteria: Patients with significant steroid-related adverse effects, intolerance to steroids, or contraindications to steroid therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chongqing medical university
Chongqing, Chongqing Municipality, 400014, China