About this trial
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 such patients. This study is a prospective, multicenter, randomized,open-label clinical trial, evaluating the efficacy and safety of steroid combined with adrenocorticotrophic hormone(ACTH) to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Adrenocorticotrophic Hormone
- Steroid
Treatment groups
Sponsors and collaborators
Mao Jianhua
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Sponsor institution
Tongji Hospital
Collaborator
Children's Hospital affiliated to Capital Institute of Pediatrics
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Children's Hospital of Nanjing Medical University
Collaborator
Kunming Children's Hospital
Collaborator
Yuying Children's Hospital of Wenzhou Medical University
Collaborator
Ningbo Women & Children's Hospital
Collaborator