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L'essai clinique NCT07388810 pour FRNS/SDNS, ripertamab est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome 312 Randomisé Ouvert

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07388810 est une étude interventionnel pour FRNS/SDNS, ripertamab. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 février 2026, avec un objectif de 312 participants. Dirigée par Mao Jianhua, l'étude devrait être terminée d'ici le 1 février 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 février 2026.
Résumé succinct
This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).
Titre officiel

Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome：An Open-label Randomized Controlled Trial

Pathologies
FRNS/SDNSripertamab
Autres identifiants de l'étude
  • SCT400-NS-ch
Numéro NCT
NCT07388810
Date de début (réel)
2026-02
Dernière mise à jour publiée
2026-02-05
Date de fin (estimée)
2028-02
Inscription (estimée)
312
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalTwo doses group
2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days).
ripertamab
2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
Comparateur actifOne dose group
1 dose of 375mg/m2 BSA ripertamab.
ripertamab
1 dose of 375mg/m2 BSA ripertamab. At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Relapse free survival rate
Relapse free survival rate at 1 year
1 year
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Recurrence frequency at 6 and 12 months
Recurrence frequency within 6 months during the study period. Recurrence frequency within 12 months during the study period.
1 year
Cumulative corticosteroid dose
Total amount of corticosteroids used in 1 year during the study period
1 year
Median recurrence-free survival
From admission day to 18 months
18 months
B-cell count
18 months
The occurrence and severity of adverse events
18 months
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant
Âge minimum
1 Year
Sexes éligibles
Tous
  1. 16 years old and above with FRNS/SDNS
  2. Before enrollment, achieved complete remission (urine protein/creatinine ratio (morning urine or 24-hour urine) ≤ 20mg/mmol (0.2mg/mg) or < 100mg/m2/d, or test strip result negative or trace)
  3. Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)
  4. Glomerular filtration rate (eGFR) > 60ml/min/1.73m2
  5. The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study

  1. Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)
  2. Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.
  3. Severe leukopenia (white blood cells < 3.0×109/L), severe anemia (hemoglobin < 8.9 g/dl), thrombocytopenia (platelets < 100×109/L), or liver dysfunction (alanine aminotransferase/aspartate aminotransferase > 2 times the upper limit of normal)
  4. Received live vaccines within 1 month prior to screening
  5. Currently participating in other drug clinical trials
  6. Other conditions that the investigator deems make the patient unsuitable for this study
Mao Jianhua logoMao Jianhua
Sinocelltech Ltd. logoSinocelltech Ltd.
Partie responsable de l'étude
Mao Jianhua, Promoteur-Investigateur, Professor, The Children's Hospital of Zhejiang University School of Medicine
Contact central de l'étude
Contact: Jianhua Mao, MD, 13516819071, [email protected]
Contact: Xuan Gang, MD, 15168358586, [email protected]
1 Centres de l'étude dans 1 pays

Zhejiang

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052, Hangzhou, Zhejiang, China