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Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial (STORM) Fase III 80 Aleatorizado

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05734794 (STORM) está diseñado para estudiar el tratamiento de Síndrome nefrótico en niños, Rituximab. Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 9 de febrero de 2023, con el objetivo de reclutar a 80 participantes. Dirigido por The Children's Hospital of Zhejiang University School of Medicine, se espera que finalice el 30 de julio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de agosto de 2023.
Resumen
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.
Descripción detallada
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 freq...Mostrar más
Título oficial

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

Condiciones médicas
Síndrome nefrótico en niñosRituximab
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • STORM
Número del NCT
NCT05734794
Inicio del estudio (real)
2023-02-09
Última actualización
2023-08-25
Fecha de finalización (estimada)
2026-07-30
Inscripción (prevista)
80
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Palabras clave
Rituximab
Glucocorticosteroids
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalRituximab Group
Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days).
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.
Comparador activoSteroid Group
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.
Esteroide
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Recurrence-free survival time(day) after first complete remission
The time from complete remission to the first relapse during the whole 52-week follow-up in patients who achieve complete remission within 6 weeks. In order to evaluate the remission, all the participants will document their proteinuria. Relapse is defined by first-morning urine dipstick ≥3+ on three or more consecutive days, 24-h PCR≥2.0g/g, or 24-h urine protein ≥ 50mg/kg, with or without edema after complete remission(KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). Complete remission is defined by the first morning or 24h PCR ≤ 0.2g/g (or negative or trace dipstick) on three or more consecutive occasions(KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases).
From complete remission to 52 weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Complete remission of nephrotic syndrome
Complete remission is defined by the first morning or 24h PCR ≤ 0.2g/g (or negative or trace dipstick) on three or more consecutive occasions (KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). It will be recorded as "1" when patients achieve complete remission, or as "0".
From admission day to 6 weeks
Inefficiency of nephrotic syndrome
Inefficiency is defined as patients still have nephrotic-range proteinuria(first-morning urine dipstick ≥3+dipstick, 24-h PCR≥2.0g/g, or 24-h urine protein ≥ 50mg/kg) after 6-week treatment.
From admission day to 6 weeks
The time(day) to first complete remission
The time(day) from the first medicine administration to complete remission within 6 weeks.Complete remission is defined by the first morning or 24h PCR ≤ 0.2g/g (or negative or trace dipstick) on three or more consecutive occasions (KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases).
From admission day to 6 weeks
Relapse of nephrotic syndrome
Relapse is defined as patients who have first-morning urine dipstick ≥3+ on three or more consecutive days, 24-h PCR≥2.0g/g, or 24-h urine protein ≥ 50mg/kg, with or without edema after complete remission(KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases). It will be recorded as "1" when patients have a relapse, or as "0".
From admission day to 52 weeks
Cumulative prednisone dosage of each individual (milligrams per kilogram per year)
The total dosage of prednisone for each individual from the beginning to the end of the trial.
From admission day to 52 weeks
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Niño
Edad mínima
2 Years
Criterios de sexo
Todos
  1. New-onset idiopathic nephrotic syndrome
  2. Glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.

  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.
The Children's Hospital of Zhejiang University School of Medicine logoThe Children's Hospital of Zhejiang University School of Medicine
Parte responsable del estudio
Mao Jianhua, Investigador principal, Associate Dean, The Children's Hospital of Zhejiang University School of Medicine
Contactos centrales del estudio
Contacto: Jianhua Mao, PHD.MD, 86057186670015, [email protected]
Contacto: Fei Liu, [email protected]
1 Centros del estudio en 1 países

Zhejiang

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Li Qiu-Yu, Contacto, 17794588355, [email protected]
Reclutando