Actively Recruiting
Study of Adrenocorticotropic Hormone on 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
165 weeks
Total Duration
On this page
Sponsors
M
Mao Jianhua
Lead Sponsor
T
Tongji Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Age 2 to 14 years old
- Diagnosed with sensitive but frequent relapsing or steroid-dependent nephrotic syndrome
- No severe hormonal side effects and/or low-dose steroid dependent nephrotic syndrome (defined as two relapses with an average dose less than 0.5 mg/kg/day or equivalent alternate-day dose)
- Normal kidney function with eGFR of 90 ml/min/1.73m2 or higher
- Morning urine protein less than 1+ or urine protein-creatinine ratio less than 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 use of rituximab or belimumab within 6 months
You will not qualify if you...
- Family history of nephrotic syndrome, chronic glomerulonephritis, uremia, or other kidney diseases
- Presence of congenital or acquired immunodeficiency or active infections such as tuberculosis, CMV, EBV, hepatitis B or C, HIV, deep fungal infection, or other active infections
- Recurrent or persistent hypertension
- Secondary nephrotic syndrome caused by diseases like lupus, diabetes, drug poisoning, or infection
- Other kidney diseases like polycystic kidney disease, ANCA vasculitis, or urinary system malformations
- Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infections, gastric or duodenal ulcers, heart failure, or serious diseases affecting heart, liver, blood, endocrine, or other systems
- Presence of other known monogenic genetic diseases affecting nephrotic syndrome
- Serious autoimmune diseases or tumors
- Use of other immunosuppressants within 3 months or rituximab or belimumab within 6 months
- Known allergy to ACTH, glucocorticoids, or components of these drugs, or severe hormone-related side effects
- History of organ transplantation (excluding corneal and hair transplantation)
- Participation in other clinical trials within 3 months prior to enrollment
- Any condition the investigator believes makes the participant unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
J
jianhua Mao, MD
CONTACT
Y
yi Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here