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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.
Sponsor: Mao Jianhua
Summary
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.
Key Details
Gender
All
Age Range
2 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2023-11-01
Completion Date
2026-12-31
Last Updated
2023-10-12
Healthy Volunteers
No
Conditions
Interventions
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) and 2.5mg qod (body surface area \< 1.0m2) and maintain the dose until study completion.
Steroid
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.
Locations (8)
Tongji Hospital
Wuhan, Hubei, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
Kunming Children's Hospital
Kunming, Yunnan, China
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
Yuying Childrens Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Children's Hospital affiliated to Capital Institute of Pediatrics
Beijing, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China