Adrenocorticotropic hormone added to steroids for children with relapsing nephrotic syndrome
Tests adding adrenocorticotropic hormone to steroids in children with relapsing nephrotic syndrome.
Key facts
- Who runs it
- Mao Jianhua
- Where
- China8 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 140 people, planned
- Started
- 1 Nov 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Adrenocorticotrophic Hormone
- Steroid
- Record updated
- 12 October 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with nephrotic syndrome that responds to steroids but often comes back or depends on steroids. It compares ACTH plus steroid with steroid alone.
- Age
- 2 to 14 years
- Sex
- All
- Disease stage
- Steroid-sensitive nephrotic syndrome with frequent relapses or steroid dependence, with no known cause (idiopathic). Normal kidney function: eGFR≥90ml/min/1.73m2. At entry, morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 days in a row or more.
- Earlier treatment
- Prednisone dose of 1.5-2 mg/kg per day before admission. No other immunosuppressants (such as tacrolimus, mycophenolate, cyclosporin A, cyclophosphamide, levamisole) within 3 months. No rituximab or belimumab within 6 months.
Main reasons for not taking part
- Family history of nephrotic syndrome or other kidney diseases
- Nephrotic syndrome caused by another illness, such as lupus, diabetes or infection, or other kidney diseases
- Weak immune system, or active infections such as tuberculosis, hepatitis B or C, or HIV
- High blood pressure, diabetes, stomach ulcers, heart failure, or serious autoimmune disease or tumors
- Allergy to ACTH or steroids, severe steroid side effects, or past organ transplant
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients who had participated in other clinical trials within three months prior to enrollment
- Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases
- Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections
- Recurrent or persistent hypertension
- Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection
- Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc
- Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infection, gastric and duodenal ulcer disease and heart failure; Patients with other serious heart, liver and other important organs, blood system, endocrine system and other system lesions
- Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome
- Patients with serious autoimmune diseases or tumors
- Patients who are known to be allergic to ACTH, glucocorticoids, or any of the components of these drugs, and patients with severe hormone-related side effects
- History of organ transplantation (excluding corneal and hair transplantation)
- 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
- Any patient whom the investigator determines is not suitable for inclusion in the trial
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 14 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Adrenocorticotrophic Hormone GroupTreatment being tested
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
Treatment: Adrenocorticotrophic Hormone
- Steroid GroupExisting treatment, for comparison
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.
Treatment: Steroid
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
- Plain-language title
- Adrenocorticotropic hormone added to steroids for children with relapsing nephrotic syndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT06079788, who can take part
- Publications
- Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children.The Cochrane database of systematic reviews, 2024
- Record updated
- 12 October 2023