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Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial. Phase III 140 Randomisé Ouvert

En recrutement
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L'essai clinique NCT06079788 est conçu pour étudier le traitement de Syndrome néphrotique chez les enfants. Il s'agit d'une étude interventionnel en Phase III. Son statut actuel est : en recrutement. L'étude a débuté le 1 novembre 2023 et vise à recruter 140 participants. Dirigée par Mao Jianhua, l'étude devrait être terminée d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 octobre 2023.
Résumé succinct
Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of ...Afficher plus
Description détaillée
Although steroids are recognized as first-line treatments for nephrotic syndrome, the vast majority of children relapse, and about half of them have frequent relapse or steroids dependence after treatment with steroids alone. Some children experienced steroids-resistance after multiple relapses, and eventually developed into chronic kidney dysfunction. Long-term or repeated application of large doses of steroids will...Afficher plus
Titre officiel

Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.

Pathologies
Syndrome néphrotique chez les enfants
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • STAIR
Numéro NCT
NCT06079788
Date de début (réel)
2023-11-01
Dernière mise à jour publiée
2023-10-12
Date de fin (estimée)
2026-12-31
Inscription (estimée)
140
Type d'étude
Interventionnel
PHASE
Phase III
Statut
En recrutement
Mots clés
Nephrotic Syndrome
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Adrenocorticotropic Hormone
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalAdrenocorticotrophic Hormone Group
ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks. Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd
Adrenocorticotrophic Hormone
For patients in complete remission, ACTH is given at a prednisone dose of 1.5-2mg/kg qod or 0.75-1mg/kg qd. ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks. Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks.If stable, taper to 5mg qod (body surface area \> 1.0m2) a...Afficher plus
Comparateur actifSteroid Group
Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg （qod） or 0.125mg/kg （qd） every 4 weeks.
Stéroïde
For patients in complete remission, Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks. If stable, taper to 5mg qod (body surface area \> 1.0m2) and 2.5mg qod (body surface area \< 1.0m2) and maintain the dose until study completion.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Recurrence-free survival time(day) within 48 weeks
Recurrence-free survival time(day) within 48 weeks
Within 48 weeks after randomization
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Number of relapses during 48 weeks follow up
Number of nephrotic syndrome relapses per patient year during the 48 weeks after randomization
Within 48 weeks after randomization
The first time to relapse
The first time to relapse after patients taking part in this study
Within 48 weeks after randomization
Cumulative prednisone dosage (milligrams per kilogram per year)
The total dosage of prednisones from the beginning to the end of the trial
Within 48 weeks after randomization
Change in renal function of the patients
The change for renal function was judged by the changes of serum creatinine and estimated glomerular filtration rate in each follow-up during the study
Within 48 weeks after randomization
Change in anthropometry and growth velocity during 48 weeks after randomization
Changes in standard deviation scores for weight, height and body mass index during 48 weeks after randomization
Within 48 weeks after randomization
Change in serum cholesterol, hemoglobin and blood albumin of the patients
The changes of serum cholesterol, hemoglobin and blood albumin in each follow-up during the study
Within 48 weeks after randomization
Incidence of infection
The incidence of infection during the study
Within 48 weeks after randomization
Adverse event
The number of harmful reactions and the types of adverse events during the study
Within 48 weeks after randomization
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant
Âge minimum
2 Years
Sexes éligibles
Tous
  1. Age 2-14 years old;
  2. Sensitive but frequent relapses or steroids dependence nephrotic syndrome
  3. No severe hormonal side effects and/or low-dose steroids dependent idiopathic nephrotic syndrome in children (defined as two relapses with an average dose < 0.5mg/kg/day or equivalent alternate-day dose)
  4. Normal renal function: eGFR≥90ml/min/1.73m2;
  5. Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll;
  6. Prednisone dose was 1.5-2 mg/kg per day before admission;
  7. No use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months.

  1. Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;
  2. Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;
  3. Recurrent or persistent hypertension;
  4. Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;
  5. Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;
  6. Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infection, gastric and duodenal ulcer disease and heart failure; Patients with other serious heart, liver and other important organs, blood system, endocrine system and other system lesions;
  7. Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome;
  8. Patients with serious autoimmune diseases or tumors;
  9. Use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months;
  10. Patients who are known to be allergic to ACTH, glucocorticoids, or any of the components of these drugs, and patients with severe hormone-related side effects
  11. History of organ transplantation (excluding corneal and hair transplantation);
  12. Patients who had participated in other clinical trials within three months prior to enrollment;
  13. Any patient whom the investigator determines is not suitable for inclusion in the trial.
Mao Jianhua logoMao Jianhua
  • 🏥Tongji Hospital
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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, 0571-87061007, [email protected]
Contact: yi Xie, [email protected]
8 Centres de l'étude dans 1 pays

Hubei

Tongji Hospital, Wuhan, Hubei, 430030, China
Jianhua Zhou, MD, Contact
Jianhua Zhou, MD, Investigateur principal
En recrutement

Jiangsu

Nanjing Children's Hospital, Nanjing, Jiangsu, 210008, China
Fei Zhao, MD, Contact
Fei Zhao, MD, Investigateur principal
En recrutement

Yunnan

Kunming Children's Hospital, Kunming, Yunnan, 650000, China
bo Zhao, MD, Contact
En recrutement

Zhejiang

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Mao Jianhua, MD, Contact, 13616819071, [email protected]
En recrutement
Ningbo Women & Children's Hospital, Ningbo, Zhejiang, 315000, China
huaqiao Qiao, MD, Contact
En recrutement
Yuying Childrens Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
xuan de Wang, MD, Contact
En recrutement
Children's Hospital affiliated to Capital Institute of Pediatrics, Beijing, 100000, China
chaoying chen, MD, Contact
En recrutement
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200000, China
guimei Guo, MD, Contact
En recrutement