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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-14
SponsorMao Jianhua

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Adrenocorticotrophic Hormone
  • Steroid

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mao Jianhua

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Sponsor institution

Tongji Hospital

Collaborator

Children's Hospital affiliated to Capital Institute of Pediatrics

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Children's Hospital of Nanjing Medical University

Collaborator

Kunming Children's Hospital

Collaborator

Yuying Children's Hospital of Wenzhou Medical University

Collaborator

Ningbo Women & Children's Hospital

Collaborator