Nephrotic Syndrome in Children Clinical Trial
Official title:
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized,Open-label Clinical 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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 14 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital affiliated to Capital Institute of Pediatrics | Beijing | |
China | Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Kunming Children's Hospital | Kunming | Yunnan |
China | Nanjing Children's Hospital | Nanjing | Jiangsu |
China | Ningbo Women & Children's Hospital | Ningbo | Zhejiang |
China | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | |
China | Yuying Childrens Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Mao Jianhua | Children's Hospital affiliated to Capital Institute of Pediatrics, Children's Hospital of Nanjing Medical University, Kunming Children's Hospital, Ningbo Women & Children's Hospital, Tongji Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Yuying Childrens Hospital of Wenzhou Medical University |
China,
Chakraborty R, Mehta A, Nair N, Nemer L, Jain R, Joshi H, Raina R. ACTH Treatment for Management of Nephrotic Syndrome: A Systematic Review and Reappraisal. Int J Nephrol. 2020 Jun 4;2020:2597079. doi: 10.1155/2020/2597079. eCollection 2020. — View Citation
Hladunewich MA, Cattran D, Beck LH, Odutayo A, Sethi S, Ayalon R, Leung N, Reich H, Fervenza FC. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar(R) Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014 Aug;29(8):1570-7. doi: 10.1093/ndt/gfu069. Epub 2014 Apr 8. — View Citation
Hogan J, Bomback AS, Mehta K, Canetta PA, Rao MK, Appel GB, Radhakrishnan J, Lafayette RA. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel. Clin J Am Soc Nephrol. 2013 Dec;8(12):2072-81. doi: 10.2215/CJN.02840313. Epub 2013 Sep 5. — View Citation
Lieberman KV, Pavlova-Wolf A. Adrenocorticotropic hormone therapy for the treatment of idiopathic nephrotic syndrome in children and young adults: a systematic review of early clinical studies with contemporary relevance. J Nephrol. 2017 Feb;30(1):35-44. doi: 10.1007/s40620-016-0308-3. Epub 2016 Apr 16. — View Citation
Wang CS, Greenbaum LA. Nephrotic Syndrome. Pediatr Clin North Am. 2019 Feb;66(1):73-85. doi: 10.1016/j.pcl.2018.08.006. — View Citation
Wong W. Idiopathic nephrotic syndrome in New Zealand children, demographic, clinical features, initial management and outcome after twelve-month follow-up: results of a three-year national surveillance study. J Paediatr Child Health. 2007 May;43(5):337-41. doi: 10.1111/j.1440-1754.2007.01077.x. — View Citation
Zand L, Canetta P, Lafayette R, Aslam N, Jan N, Sethi S, Fervenza FC. An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression. Kidney Int Rep. 2019 Oct 31;5(1):58-65. doi: 10.1016/j.ekir.2019.10.007. eCollection 2020 Jan. Erratum In: Kidney Int Rep. 2020 Mar 03;5(3):382. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence-free survival time(day) within 48 weeks | Recurrence-free survival time(day) within 48 weeks | Within 48 weeks after randomization | |
Secondary | Number of relapses during 48 weeks follow up | Number of nephrotic syndrome relapses per patient year during the 48 weeks after randomization | Within 48 weeks after randomization | |
Secondary | The first time to relapse | The first time to relapse after patients taking part in this study | Within 48 weeks after randomization | |
Secondary | Cumulative prednisone dosage (milligrams per kilogram per year) | The total dosage of prednisones from the beginning to the end of the trial | Within 48 weeks after randomization | |
Secondary | Change in renal function of the patients | The change for renal function was judged by the changes of serum creatinine and estimated glomerular filtration rate in each follow-up during the study | Within 48 weeks after randomization | |
Secondary | Change in anthropometry and growth velocity during 48 weeks after randomization | Changes in standard deviation scores for weight, height and body mass index during 48 weeks after randomization | Within 48 weeks after randomization | |
Secondary | Change in serum cholesterol, hemoglobin and blood albumin of the patients | The changes of serum cholesterol, hemoglobin and blood albumin in each follow-up during the study | Within 48 weeks after randomization | |
Secondary | Incidence of infection | The incidence of infection during the study | Within 48 weeks after randomization | |
Secondary | Adverse event | The number of harmful reactions and the types of adverse events during the study | Within 48 weeks after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05044169 -
Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
|
N/A | |
Recruiting |
NCT05588063 -
taVNS for FRNS in Children
|
N/A | |
Recruiting |
NCT05583942 -
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
|
N/A | |
Recruiting |
NCT06125405 -
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
|
Phase 3 | |
Completed |
NCT04034316 -
Reduce Immunosuppression With Atmp in NS ChildrEn
|
Phase 2 | |
Completed |
NCT04048161 -
Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome
|
Phase 4 | |
Enrolling by invitation |
NCT04571658 -
NEPTUNE Match Study
|
||
Recruiting |
NCT06417320 -
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
|
Phase 4 | |
Recruiting |
NCT05843968 -
Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
|
Phase 2 | |
Recruiting |
NCT05734794 -
Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
|
Phase 3 | |
Not yet recruiting |
NCT06130631 -
Predictors of Steroid Response in Childhood Nephrotic Syndrome
|
||
Terminated |
NCT03878914 -
Steroid Sensitive Nephrotic Syndrome in Children
|
Phase 4 | |
Recruiting |
NCT03786263 -
CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study
|
||
Recruiting |
NCT05772871 -
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
|
Phase 4 | |
Recruiting |
NCT05505500 -
Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
|