Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome
NCT ID: NCT04048161
Last Updated: 2023-10-17
Study Results
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Basic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2019-11-12
2023-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tacrolimus(Group A)
Tacrolimus: 0.5mg and 1mg; Capsule; 0.05-0.10mg/kg/day，BID; Steroid: 5mg; Oral tablets; 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd;
Tacrolimus
The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml，then reduce the dosage of drugs to maintian the concentration for tacrolimus is \< 5ng/ml. Total duration : 1 year.
Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.
Mycophenolate Mofetil(Group B)
Mycophenolate Mofetil: 250mg; Dispersible tablets; 20\~30mg/kg/day，BID; Steroid: 5mg; Oral tablets; 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd;
Mycophenolate Mofetil
The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20\~30mg/kg/day，BID. The concentration for MPA-AUC is 30\~50 μg.h/ml，then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year.
Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.
Interventions
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Tacrolimus
The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml，then reduce the dosage of drugs to maintian the concentration for tacrolimus is \< 5ng/ml. Total duration : 1 year.
Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.
Mycophenolate Mofetil
The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20\~30mg/kg/day，BID. The concentration for MPA-AUC is 30\~50 μg.h/ml，then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year.
Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 2 to 18 years old
* Normal renal function: estimated glomerular filtration rate ≥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
* No tacrolimus, mycophenolate mofetil, cyclosporine A, rituximab or cyclophosphamide was used within 2 years prior to the enrollment
Exclusion Criteria
* Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
* Leukopenia (White Blood Cells ≤ 3.0 \* 10\^9 / L)
* Moderate to severe anemia (hemoglobin \<9.0 g/dL)
* Thrombocytopenia (platelet count \<100\*10\^12/L)
* Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
* There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness
* Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)
* Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney
* Those who with other autoimmune diseases or primary immunodeficiencies or tumors
* Those who was known to be sensitized to tacrolimus, mycophenolate mofetil, glucocorticoids, or any of the above drugs
* Those who have participated in other clinical trials within three months prior to the enrollment
* Those who was not suitable for participating this study judged by investigator
2 Years
18 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Peking University First Hospital
OTHER
First Affiliated Hospital of Zhongshan Medical University
OTHER
Nanjing Children's Hospital
OTHER
Chengdu Women and Children's Center Hospital
OTHER
Tongji Hospital
OTHER
Second Xiangya Hospital of Central South University
OTHER
Children's Hospital of Chongqing Medical University
OTHER
Children's Hospital of Soochow University
OTHER
Henan Provincial People's Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Responsible Party
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Mao Jianhua
Chief Physician
Principal Investigators
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Jianhua Mao, MD
Role: STUDY_CHAIR
Children's Hospital, Zhejiang University School of Medicine
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Zhongshan Medical University
Guangzhou, Guangdong, China
Henan Children's Hospital
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Shandong Provincial Hospital
Jinan, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Women and Children's Center Hospital
Chengdu, Shichuan, China
The Children Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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References
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Ren H, Shen P, Li X, Pan X, Zhang W, Chen N. Tacrolimus versus cyclophosphamide in steroid-dependent or steroid-resistant focal segmental glomerulosclerosis: a randomized controlled trial. Am J Nephrol. 2013;37(1):84-90. doi: 10.1159/000346256. Epub 2013 Jan 22.
Filler G, Young E, Geier P, Carpenter B, Drukker A, Feber J. Is there really an increase in non-minimal change nephrotic syndrome in children? Am J Kidney Dis. 2003 Dec;42(6):1107-13. doi: 10.1053/j.ajkd.2003.08.010.
Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. doi: 10.1016/S0140-6736(03)14184-0.
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.
Tarshish P, Tobin JN, Bernstein J, Edelmann CM Jr. Prognostic significance of the early course of minimal change nephrotic syndrome: report of the International Study of Kidney Disease in Children. J Am Soc Nephrol. 1997 May;8(5):769-76. doi: 10.1681/ASN.V85769.
Shaw KT, Ho AM, Raghavan A, Kim J, Jain J, Park J, Sharma S, Rao A, Hogan PG. Immunosuppressive drugs prevent a rapid dephosphorylation of transcription factor NFAT1 in stimulated immune cells. Proc Natl Acad Sci U S A. 1995 Nov 21;92(24):11205-9. doi: 10.1073/pnas.92.24.11205.
Koefoed-Nielsen PB, Karamperis N, Hojskov C, Poulsen JH, Jorgensen KA. The calcineurin activity profiles of cyclosporin and tacrolimus are different in stable renal transplant patients. Transpl Int. 2006 Oct;19(10):821-7. doi: 10.1111/j.1432-2277.2006.00359.x.
Neidle S, Goodwin GH. A homology-based molecular model of the proline-rich homeodomain protein Prh, from haematopoietic cells. FEBS Lett. 1994 May 30;345(2-3):93-8. doi: 10.1016/0014-5793(94)00446-3.
Sepe V, Libetta C, Giuliano MG, Adamo G, Dal Canton A. Mycophenolate mofetil in primary glomerulopathies. Kidney Int. 2008 Jan;73(2):154-62. doi: 10.1038/sj.ki.5002653. Epub 2007 Nov 7.
Briggs WA, Choi MJ, Scheel PJ Jr. Successful mycophenolate mofetil treatment of glomerular disease. Am J Kidney Dis. 1998 Feb;31(2):213-7. doi: 10.1053/ajkd.1998.v31.pm9469489.
Gellermann J, Weber L, Pape L, Tonshoff B, Hoyer P, Querfeld U; Gesellschaft fur Padiatrische Nephrologie (GPN). Mycophenolate mofetil versus cyclosporin A in children with frequently relapsing nephrotic syndrome. J Am Soc Nephrol. 2013 Oct;24(10):1689-97. doi: 10.1681/ASN.2012121200. Epub 2013 Jun 27.
Schwartz GJ, Brion LP, Spitzer A. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987 Jun;34(3):571-90. doi: 10.1016/s0031-3955(16)36251-4.
Wang J, Liu F, Yan W, Zhou J, Zhang Y, Rong L, Jiang X, Zhao F, Zhu C, Wu X, Li X, Sun S, Wang J, Wang M, Yang Q, Xu H, Chen J, Liu C, Tian M, Feng S, Duan Q, Zhong X, Zhu Y, Li X, Fu H, Huang L, Ma D, Ding J, Ye Q, Mao J. Tacrolimus or Mycophenolate Mofetil for Frequently Relapsing or Steroid-Dependent Nephrotic Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2025 May 12;179(7):722-9. doi: 10.1001/jamapediatrics.2025.0765. Online ahead of print.
Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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STAMP
Identifier Type: -
Identifier Source: org_study_id
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