NCT06079788 Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
| NCT ID | NCT06079788 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mao Jianhua |
| Condition | Nephrotic Syndrome in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2023-11-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
yi Xie
STUDY DIRECTOR
Recruiting
Frequently Asked Questions
Who can join the NCT06079788 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 14 Years, studying Nephrotic Syndrome in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06079788 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT06079788 currently recruiting?
Yes, NCT06079788 is actively recruiting participants. Contact the research team at maojh88@126.com for enrollment information.
Where is the NCT06079788 trial being conducted?
This trial is being conducted at Wuhan, China, Nanjing, China, Kunming, China, Hangzhou, China and 4 additional locations.
Who is sponsoring the NCT06079788 clinical trial?
NCT06079788 is sponsored by Mao Jianhua. The principal investigator is yi Xie at Recruiting. The trial plans to enroll 140 participants.