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.
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 lead to side effects such as obesity, growth retardation, and hypertension. Although the treatment of steroids with immunosuppressive agents is a new choice for the treatment of such patients, traditional immunosuppressive agents will bring some serious irreversible side effects. The clinical application of ACTH in children with nephrotic syndrome dates back to the late 1940s. In recent years, the new mechanism of action of ACTH is also being explored. A number of clinical studies on the treatment of nephrotic syndrome by ACTH have found that it can still achieve good efficacy in patients who are ineffective in first-line treatment. This study evaluated the efficacy of ACTH in the treatment of relapsing or steroid-dependent nephrotic syndrome in children, in order to provide a more effective and safer treatment for children with nephrotic syndrome as well as the therapeutic medication options.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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) and 2.5mg qod (body surface area \< 1.0m2) and maintain the dose until study completion.
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.
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGNanjing Children's Hospital
Nanjing, Jiangsu, China
RECRUITINGKunming Children's Hospital
Kunming, Yunnan, China
RECRUITINGChildren's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGNingbo Women & Children's Hospital
Ningbo, Zhejiang, China
RECRUITINGYuying Childrens Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGChildren's Hospital affiliated to Capital Institute of Pediatrics
Beijing, China
RECRUITINGXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGRecurrence-free survival time(day) within 48 weeks
Recurrence-free survival time(day) within 48 weeks
Time frame: Within 48 weeks after randomization
Number of relapses during 48 weeks follow up
Number of nephrotic syndrome relapses per patient year during the 48 weeks after randomization
Time frame: Within 48 weeks after randomization
The first time to relapse
The first time to relapse after patients taking part in this study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within 48 weeks after randomization
Incidence of infection
The incidence of infection during the study
Time frame: Within 48 weeks after randomization
Adverse event
The number of harmful reactions and the types of adverse events during the study
Time frame: Within 48 weeks after randomization
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