Evaluating Rituximab for Children with New-onset Nephrotic Syndrome

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

This study is testing if Rituximab can be a better treatment than steroids for children with newly diagnosed nephrotic syndrome.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine (Academic / other)
• Drugs / interventions: rituximab, cyclophosphamide
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05734794 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of Rituximab monotherapy compared to traditional steroid therapy in treating children with new-onset nephrotic syndrome over a 52-week period. Nephrotic syndrome is a common glomerular disease in children, and while steroids have been the standard treatment, they can cause significant adverse effects. Rituximab, a monoclonal antibody targeting CD20, has shown promise in adult patients and in those with frequent relapses, but its efficacy in new-onset pediatric cases remains unclear. The study will involve a randomized controlled design to provide robust data on the outcomes of both treatment approaches.

Who should consider this trial

Good fit: Ideal candidates for this study are children diagnosed with new-onset idiopathic nephrotic syndrome and with normal kidney function.

Not a fit: Patients with secondary nephrotic syndrome or those with complicating kidney diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a safer, steroid-sparing treatment option for children with nephrotic syndrome.

How similar studies have performed: Previous studies have shown success with Rituximab in treating frequent-relapse nephrotic syndrome, but its use in new-onset pediatric cases is still being explored.

Eligibility criteria

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.
11. With tumor, severe cardiac failure, severe hepatologic diseases, hematological diseases, or other severe system diseases.
12. Patients who are known to be allergic to rituximab;
13. History of transplantation, excluding cornea or hair transplantation;
14. The attenuated live vaccine was inoculated within 1 month before enrollment;
15. Patients who participated in other clinical trials within three months before enrollment;
16. Patients are not suitable for inclusion in the trial by any investigator.

Where this trial is running

Hangzhou, Zhejiang

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jianhua Mao, PHD.MD

Conditions Nephrotic Syndrome in Children; Rituximab; Glucocorticosteroids