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Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT05734794•The Children's Hospital of Zhejiang University School of Medicine

View on ClinicalTrials.gov

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.

Detailed Description

Nephrotic syndrome(NS) -------the most common glomerular disease in children. Steroid, as the mainstream therapy for decades, many patients suffer from adverse effects of it, such as growth impacted, fat, and glaucoma.There is a urgent need for Steroid-sparing therapy. Rituximab, as a chemical monoclonal antibody against the cluster of differentiation antigen 20(CD20), has proved to be effective in patients with frequent-relapse/steroid-dependent NS. It has also been reported to be effective in six adult patients with new-onset NS. Rituximab mono-therapy in new-onset pediatric NS patients is still unclear.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. New-onset idiopathic nephrotic syndrome
•2. Glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.

Exclusion Criteria

•1. Glomerular hematuria: Urine red blood cell counts≥ 10/high power field(HP), ≥ 3 times within 2 weeks;
•2. Continuous hypocomplementaemia(\< 0.9g/L) ;
•3. Repeated or persistent Hypertension(systolic and/or diastolic blood pressures measured greater than the 95th percent of blood pressure in children matching sex, age and height ≥3 different time points)
•4. Diagnosis of secondary NS, such as secondary to Systemic Lupus Erythematosus, Immunoglobulin A Vasculitis(IgAV), diabetes, Hepatitis B virus(HBV) infection, etc.
•5. Complicated with other kidney diseases, such as multiple renal cysts, ANCA vasculitis, urinary system abnormalities, etc;
•6. With a family history of nephrotic syndrome, chronic glomerulonephritis, uremia, or other kidney diseases;
•7. Other monogenic genetic diseases known as the effect the condition of nephrotic syndromes, such as Wilms' tumor 1(WT1), NPHS2, LAMB2, PLCE1, etc.
•8. Congenital or acquired immunodeficiency, or patients with active tuberculosis, active Epstein-Barr virus and cytomegalovirus(CMV), acute hepatitis B, hepatitis C, HIV infection, deep fungal infection or other active infections.
•9. Laboratory indicators were abnormal, such as moderate or severe neutropenia(≤1000/μL)， moderate or severe anemia(hemoglobin\<9.0g/dL), Thrombocytopenia (platelet count\<100\* 10\^12/L) or with abnormal hepatic function (Alaninetransaminase(ALT), aspartate Aminotransferase(AST) or bilirubin \>2.5\*upper limit of normal value and continue to increase for 2 weeks);
•10. Steroid or immunosuppressive medicine for other diseases within 3 months, such as cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, tripterygium wilfordii, etc.
+6 more criteria

Locations (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

February 9, 2023

Primary Completion Date

December 25, 2025

Completion Date

July 30, 2026

Last Updated

August 25, 2023

Enrollment

ESTIMATED participants

Conditions

Nephrotic Syndrome in ChildrenRituximab

Interventions

Rituximab

DRUG

Steroid

DRUG

Contacts

Jianhua Mao, PHD.MD

CONTACT

86057186670015 maojh88@zju.edu.cn

Fei Liu

CONTACT

alexdevin@163.com

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

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Fluid OverloadGlomerulosclerosis, Focal Segmental+11 more

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RECRUITINGPHASE3

REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE)

NCT06635720

Nephrotic Syndrome in ChildrenNephrotic Syndrome, Minimal Change+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

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