Clinical trial
Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
Name
STORM
Description
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.
Trial arms
Trial start
2023-02-09
Estimated PCD
2025-12-25
Trial end
2026-07-30
Status
Recruiting
Phase
Early phase I
Treatment
Rituximab
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.
Arms:
Rituximab Group
Steroid
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.
Arms:
Steroid Group
Size
80
Primary endpoint
Recurrence-free survival time(day) after first complete remission
From complete remission to 52 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-08-25
1 organization
1 product
1 drug
2 indications
Drug
VarlilumabIndication
Nephrotic Syndrome in ChildrenIndication
RituximabProduct
Steroid