Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephr… (NCT06079788) | Clinical Trial Compass
RecruitingPhase 3
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
China140 participantsStarted 2023-11-01
Plain-language summary
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.
Who can participate
Age range2 Years – 14 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;
What they're measuring
1
Recurrence-free survival time(day) within 48 weeks
. 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;