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Die klinische Studie NCT05734794 (STORM) für Nephrotisches Syndrom bei Kindern, Rituximab ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial (STORM) Phase 3 80 Randomisiert

Offene Rekrutierung
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Die klinische Studie NCT05734794 (STORM) untersucht Behandlung im Zusammenhang mit Nephrotisches Syndrom bei Kindern, Rituximab. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 9. Februar 2023. Es ist geplant, 80 Teilnehmer aufzunehmen. Durchgeführt von The Children's Hospital of Zhejiang University School of Medicine wird der Abschluss für 30. Juli 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. August 2023 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Nephrotisches Syndrom bei KindernRituximab
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • STORM
NCT-Nummer
NCT05734794
Studienbeginn (tatsächlich)
2023-02-09
Zuletzt aktualisiert
2023-08-25
Studienende (vorauss.)
2026-07-30
Geplante Rekrutierung
80
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Rituximab
Glucocorticosteroids
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellRituximab 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.
Aktives VergleichspräparatSteroid 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.
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind
Mindestalter
2 Years
Zugelassene Geschlechter
Alle
  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
Verantwortliche Partei
Mao Jianhua, Hauptprüfer, Associate Dean, The Children's Hospital of Zhejiang University School of Medicine
Zentrale Studienkontakte
Kontakt: Jianhua Mao, PHD.MD, 86057186670015, [email protected]
Kontakt: Fei Liu, [email protected]
1 Studienstandorte in 1 Ländern

Zhejiang

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