Clinical Study of Adrenocorticotropic Hormone with Steroids for Children Aged 2 to 14 Years With Frequent Relapse or Steroid-Dependent Nephrotic Syndrome

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 IUkg 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 mgkg every other day or 0.75-1 mgkg 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.

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