Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized,Open-label Clinical Trial.
Nephrotic Syndrome in Children
About this trial
This is an interventional treatment trial for Nephrotic Syndrome in Children focused on measuring Nephrotic Syndrome, Frequently Relapsing Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome, Adrenocorticotropic Hormone
Eligibility Criteria
Inclusion Criteria: Age 2-14 years old; Sensitive but frequent relapses or steroids dependence nephrotic syndrome 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) Normal renal function: eGFR≥90ml/min/1.73m2; Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll; Prednisone dose was 1.5-2 mg/kg per day before admission; 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. Exclusion Criteria: Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases; 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; Recurrent or persistent hypertension; Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection; Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.; 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; Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome; Patients with serious autoimmune diseases or tumors; 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; 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 History of organ transplantation (excluding corneal and hair transplantation); Patients who had participated in other clinical trials within three months prior to enrollment; Any patient whom the investigator determines is not suitable for inclusion in the trial.
Sites / Locations
- Tongji HospitalRecruiting
- Nanjing Children's HospitalRecruiting
- Kunming Children's HospitalRecruiting
- Children's Hospital, Zhejiang University School of MedicineRecruiting
- Ningbo Women & Children's HospitalRecruiting
- Yuying Childrens Hospital of Wenzhou Medical UniversityRecruiting
- Children's Hospital affiliated to Capital Institute of PediatricsRecruiting
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Adrenocorticotrophic Hormone Group
Steroid 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
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.