NCT05734794 Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
| NCT ID | NCT05734794 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Condition | Nephrotic Syndrome in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-02-09 |
| Primary Completion | 2025-12-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2023-02-09 with a primary completion date of 2025-12-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05734794 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Nephrotic Syndrome in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05734794 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT05734794 currently recruiting?
Yes, NCT05734794 is actively recruiting participants. Contact the research team at maojh88@zju.edu.cn for enrollment information.
Where is the NCT05734794 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05734794 clinical trial?
NCT05734794 is sponsored by The Children's Hospital of Zhejiang University School of Medicine. The trial plans to enroll 80 participants.