RecruitingPhase 3NCT05734794

Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial

Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial


Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

80 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial tests rituximab (a drug that targets and removes a type of immune cell called B-cells) as an initial treatment for children newly diagnosed with nephrotic syndrome — a kidney condition where the kidneys leak large amounts of protein into the urine. Standard treatment involves steroids, but these have side effects and the condition often relapses. This study tests whether rituximab can achieve remission while reducing long-term steroid exposure. **Your child may be eligible if...** - They have been newly diagnosed with idiopathic (no clear cause) nephrotic syndrome - Their kidney filtering function is in the normal range **Your child may NOT be eligible if...** - They have blood in the urine, low complement levels, or persistent high blood pressure - Their nephrotic syndrome is caused by another condition (e.g., lupus, hepatitis B, diabetes) - They have other kidney diseases, a family history of inherited kidney disorders, or a genetic condition affecting the kidneys - They have an immune deficiency, active infection (including tuberculosis, hepatitis, HIV), or severe blood count abnormalities - They have received immunosuppressive drugs in the past 3 months - They are allergic to rituximab - They received a live vaccine within the past month Talk to your doctor to see if this trial is right for your child.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days), associated with trimethoprim-sulfamethoxazole(25-50 mg/kg/day orally twice per day, 3 days per week. If the patient is not allergic) for three months from the first rituximab dosing date(Day 1). Four doses of rituximab are necessary whether the patient achieves complete remission.

DRUGSteroid

Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks. Vitamin D and calcium(adjusted according to the blood calcium level) were administered for three months.


Locations(1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05734794


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