Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized,Open-label Clinical Trial.

PHASE3RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2026

Conditions
Nephrotic Syndrome in Children
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.

Trial Locations (8)

100000

RECRUITING

Children's Hospital affiliated to Capital Institute of Pediatrics, Beijing

200000

RECRUITING

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

210008

RECRUITING

Nanjing Children's Hospital, Nanjing

315000

RECRUITING

Ningbo Women & Children's Hospital, Ningbo

325000

RECRUITING

Yuying Childrens Hospital of Wenzhou Medical University, Wenzhou

430030

RECRUITING

Tongji Hospital, Wuhan

650000

RECRUITING

Kunming Children's Hospital, Kunming

Unknown

RECRUITING

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
collaborator

Tongji Hospital

OTHER

collaborator

Children's Hospital affiliated to Capital Institute of Pediatrics

UNKNOWN

collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Children's Hospital of Nanjing Medical University

OTHER

collaborator

Kunming Children's Hospital

OTHER

collaborator

Yuying Childrens Hospital of Wenzhou Medical University

UNKNOWN

collaborator

Ningbo Women & Children's Hospital

OTHER

lead

Mao Jianhua

OTHER