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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 14
Healthy Volunteers: f
View:

• 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;

• Morning urine protein \<1+ or urine protein-creatinine ratio \<0.2g/g (\<20 mg/mmol) for 3 consecutive days and above when in enroll;

• Prednisone dose was 1.5-2 mg/kg per day before admission;

• No use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months.

Locations
Other Locations
China
Children's Hospital affiliated to Capital Institute of Pediatrics
RECRUITING
Beijing
Children's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Kunming Children's Hospital
RECRUITING
Kunming
Nanjing Children's Hospital
RECRUITING
Nanjing
Ningbo Women & Children's Hospital
RECRUITING
Ningbo
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Yuying Childrens Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
jianhua Mao, MD
maojh88@126.com
0571-87061007
Backup
yi Xie
ylfx27@163.com
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 140
Treatments
Experimental: Adrenocorticotrophic Hormone Group
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
Active_comparator: Steroid Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Nanjing Medical University, Kunming Children's Hospital, Ningbo Women & Children's Hospital, Tongji Hospital, Yuying Childrens Hospital of Wenzhou Medical University, Children's Hospital affiliated to Capital Institute of Pediatrics
Leads: Mao Jianhua

This content was sourced from clinicaltrials.gov