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RECRUITING
NCT06079788
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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