Nephrotic Syndrome.
Chia-Shi Wang, Larry A Greenbaum
https://pubmed.ncbi.nlm.nih.gov/30454752Actively Recruiting
Phase 3
Age: 2Years - 14Years
All Genders
ID06079788
Study of Adrenocorticotropic Hormone Combined With Steroids for Children With Frequent Relapse or Steroid-Dependent Nephrotic Syndrome: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial
Led by Mao Jianhua · Updated on 2023-10-12
140
Participants Needed
8
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Mao Jianhua
Lead Sponsor
T
Tongji Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Nephrotic syndrome is a common kidney disease in children, with primary nephrotic syndrome making up about 90% of cases. While steroids are the usual first treatment, many children relapse frequently or become dependent on steroids, which can cause side effects. This trial is a prospective, randomized, open-label study investigating whether combining steroids with adrenocorticotrophic hormone (ACTH) provides better treatment options for children with frequently relapsing or steroid-dependent nephrotic syndrome. Participants are randomly assigned to two groups: one receives ACTH at a dose of 2 IU/kg daily for 5 days continuously over 28-day cycles for 24 weeks combined with prednisone, and the other receives prednisone alone with a gradual tapering schedule. Prednisone doses start at 1.5-2 mg/kg every other day or 0.75-1 mg/kg daily, with tapering every 4 weeks to a maintenance dose until the study ends. During the 48-week study period, children will be monitored for relapse-free survival, number and timing of relapses, changes in kidney function, growth measurements, and blood markers like cholesterol and albumin. Safety is evaluated by tracking infections and adverse events. The study aims to find safer and more effective individualized treatments for children with this condition, with all assessments performed regularly throughout the trial.
CONDITIONS
Brief Title
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
Who Can Participate
Age: 2Years - 14Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 14 years old
- Diagnosed with frequent relapse or steroid-dependent nephrotic syndrome
- No severe hormonal side effects and/or low-dose steroid-dependent nephrotic syndrome (two relapses with average dose less than 0.5 mg/kg/day or equivalent alternate-day dose)
- Normal kidney function with eGFR ≥ 90 ml/min/1.73m2
- Morning urine protein less than 1+ or urine protein-creatinine ratio below 0.2 g/g for 3 consecutive days at enrollment
- Prednisone dose of 1.5-2 mg/kg per day before admission
- No use of other immunosuppressants within 3 months and no rituximab or belimumab use within 6 months
You will not qualify if you...
- Family history of nephrotic syndrome, chronic glomerulonephritis, uremia, or other kidney diseases
- Congenital or acquired immunodeficiency or active infections such as tuberculosis, CMV, EBV, hepatitis B or C, HIV, or fungal infections
- Recurrent or persistent hypertension
- Secondary nephrotic syndrome due to lupus, diabetes, drug poisoning, or infection
- Other kidney diseases like polycystic kidney, ANCA vasculitis, or urinary malformations
- Serious diseases including hypertension, diabetes, gastric ulcers, heart failure, or lesions in major organs or systems
- Known genetic diseases affecting nephrotic syndrome
- Serious autoimmune diseases or tumors
- Recent or current use of other immunosuppressants within 3 to 6 months
- Allergy to ACTH, glucocorticoids, or drug components; severe hormone-related side effects
- History of organ transplantation (excluding corneal or hair)
- Participation in other clinical trials within 3 months
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants receive either Adrenocorticotropic Hormone combined with steroids or steroids alone to treat frequent relapse or steroid-dependent nephrotic syndrome.
Regular visits during 24 weeks of treatment
Follow-up
Duration - Up to 48 weeks after randomization
Participants are monitored for up to 48 weeks after randomization to assess recurrence-free survival, number of relapses, and other health outcomes.
Visits as scheduled during the follow-up period
Trial Site Locations
Total: 8 locations
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
2
Nanjing Children's Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
3
Kunming Children's Hospital
Kunming, Yunnan, China, 650000
Actively Recruiting
4
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
5
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China, 315000
Actively Recruiting
6
Yuying Childrens Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
7
Children's Hospital affiliated to Capital Institute of Pediatrics
Beijing, China, 100000
Actively Recruiting
8
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200000
Actively Recruiting
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Research Team
J
jianhua Mao, MD
Y
yi Xie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Idiopathic nephrotic syndrome in New Zealand children, demographic, clinical features, initial management and outcome after twelve-month follow-up: results of a three-year national surveillance study.
William Wong
https://pubmed.ncbi.nlm.nih.gov/17489822ACTH Treatment for Management of Nephrotic Syndrome: A Systematic Review and Reappraisal.
Ronith Chakraborty, Arul Mehta, Nikhil Nair...
https://pubmed.ncbi.nlm.nih.gov/32566293Adrenocorticotropic hormone therapy for the treatment of idiopathic nephrotic syndrome in children and young adults: a systematic review of early clinical studies with contemporary relevance.
Kenneth V Lieberman, Anna Pavlova-Wolf
https://pubmed.ncbi.nlm.nih.gov/27084801A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar® Gel) in nephrotic syndrome due to idiopathic membranous nephropathy.
Michelle A Hladunewich, Daniel Cattran, Laurence H Beck...
https://pubmed.ncbi.nlm.nih.gov/24714414Treatment of idiopathic FSGS with adrenocorticotropic hormone gel.
Jonathan Hogan, Andrew S Bomback, Kshama Mehta...
https://pubmed.ncbi.nlm.nih.gov/24009220An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression.
Ladan Zand, Pietro Canetta, Richard Lafayette...
https://pubmed.ncbi.nlm.nih.gov/31922061Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children.
Nicholas G Larkins, Deirdre Hahn, Isaac D Liu...
https://pubmed.ncbi.nlm.nih.gov/39513526