Status:
RECRUITING
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
Lead Sponsor:
Mao Jianhua
Collaborating Sponsors:
Tongji Hospital
Children's Hospital affiliated to Capital Institute of Pediatrics
Conditions:
Nephrotic Syndrome in Children
Eligibility:
All Genders
2-14 years
Phase:
PHASE3
Brief 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 stero...
Detailed Description
Although steroids are recognized as first-line treatments for nephrotic syndrome, the vast majority of children relapse, and about half of them have frequent relapse or steroids dependence after treat...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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;
- 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);
- Patients who had participated in other clinical trials within three months prior to enrollment;
- Any patient whom the investigator determines is not suitable for inclusion in the trial.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06079788
Start Date
November 1 2023
End Date
December 31 2026
Last Update
October 12 2023
Active Locations (8)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030
2
Nanjing Children's Hospital
Nanjing, Jiangsu, China, 210008
3
Kunming Children's Hospital
Kunming, Yunnan, China, 650000
4
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China