Using Adrenocorticotropic Hormone to Treat Children with Nephrotic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining adrenocorticotropic hormone (ACTH) with steroids in treating children aged 2-14 who suffer from frequently relapsing or steroid-dependent nephrotic syndrome. The study is multicenter and randomized, aiming to provide individualized treatment options for these patients. By exploring the efficacy of ACTH, the trial seeks to offer a safer alternative to traditional steroid treatments, which can lead to significant side effects. The goal is to improve outcomes for children who do not respond well to standard therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 2-14 years old;
2. Sensitive but frequent relapses or steroids dependence nephrotic syndrome
3. 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)
4. Normal renal function: eGFR≥90ml/min/1.73m2;
5. Morning urine protein \<1+ or urine protein-creatinine ratio \<0.2g/g (\<20 mg/mmol) for 3 consecutive days and above when in enroll;
6. Prednisone dose was 1.5-2 mg/kg per day before admission;
7. 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.

Exclusion Criteria:

1. Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;
2. 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;
3. Recurrent or persistent hypertension;
4. Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;
5. Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;
6. 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;
7. Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome;
8. Patients with serious autoimmune diseases or tumors;
9. 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;
10. 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
11. History of organ transplantation (excluding corneal and hair transplantation);
12. Patients who had participated in other clinical trials within three months prior to enrollment;
13. Any patient whom the investigator determines is not suitable for inclusion in the trial.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting
• Nanjing Children's Hospital
  Nanjing, Jiangsu, China Recruiting
• Kunming Children's Hospital
  Kunming, Yunnan, China Recruiting
• Children's Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Ningbo Women & Children's Hospital
  Ningbo, Zhejiang, China Recruiting
• Yuying Childrens Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: jianhua Mao, MD
• Email: maojh88@126.com
• Phone: 0571-87061007

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dupilumab for nephrotic syndrome in children

  This study will try dupilumab to help children with steroid‑dependent or frequently relapsing nephrotic syndrome stay in remission and relapse less often.

  Recruiting at 2 sites Phase 2 National University Hospital, Singapore · Singapore, Singapore and 1 other locations · NCT07091175

• SG301 (anti-CD38) injection for children with frequently relapsing or steroid-dependent nephrotic syndrome

  This Phase 2 trial will test whether SG301 (an anti-CD38 antibody) injections are safe and help children aged 6–18 who have frequently relapsing or steroid‑dependent nephrotic syndrome.

  Recruiting Phase 2 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07087314

• Evaluating Telitacicept for Children with Nephrotic Syndrome

  This study is testing if a new treatment called telitacicept can help children with nephrotic syndrome feel better and have fewer side effects than the usual medications.

  Recruiting Phase 3 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT06125405

• Vagus nerve stimulation for treating nephrotic syndrome in children

  This study is testing whether a new treatment using vagus nerve stimulation can help children aged 3 to 17 with nephrotic syndrome feel better and reduce their symptoms.

  Recruiting at 2 sites Northwell Health · New Hyde Park, New York and 1 other locations · NCT05588063

• Using vagus nerve stimulation to treat nephrotic syndrome in children

  This study is testing if a new type of nerve stimulation can help children with steroid-resistant nephrotic syndrome feel better over 26 weeks.

  Recruiting at 2 sites Northwell Health · New Hyde Park, New York and 1 other locations · NCT05583942

• Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome

  This study talks to patients and parents about their experiences with swelling from Nephrotic Syndrome to help create better ways to measure how new treatments work.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT05505500

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.