Long term tapering versus standard prednisolone treatment for first episode of childhood nephrotic syndrome: Phase III randomised controlled trial and economic evaluation

The BMJ

Volumn 365, Issue , 2019, Pages

  Webb, Nicholas J A ^a,b   Woolley, Rebecca L ^c   Lambe, Tosin ^c   Frew, Emma ^c   Brettell, Elizabeth A ^c   Barsoum, Emma N ^c   Trompeter, Richard S ^d   Cummins, Carole ^c   Deeks, Jonathan J ^c,e   Wheatley, Keith ^c   Ives, Natalie J ^c  

^a ROYAL MANCHESTER CHILDREN S HOSPITAL   (United Kingdom)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

^c UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

^e UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; PREDNISOLONE;

ABDOMINAL PAIN; ACNE; ADOLESCENT; ARTICLE; BEHAVIOR DISORDER; BODY MASS; CATARACT; CHILD; CHILD BEHAVIOR CHECKLIST; CHILDHOOD DISEASE; CLINICAL FEATURE; CLINICAL OUTCOME; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DISEASE ASSOCIATION; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ECONOMIC EVALUATION; ETHNICITY; EVIDENCE BASED PRACTICE; FEMALE; FOLLOW UP; GLUCOSURIA; HEALTH CARE COST; HUMAN; HYPERTRICHOSIS; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; INCREASED APPETITE; MAJOR CLINICAL STUDY; MALE; MOON FACE; MULTICENTER STUDY; NEPHROTIC SYNDROME; PHASE 3 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; STRIA; TERTIARY CARE CENTER; TREATMENT DURATION; UNITED KINGDOM;

EID: 85066009544     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.l1800     Document Type: Article

References (26)

1. McKinney PA, Feltbower RG, Brocklebank JT, Fitzpatrick MM. Time trends and ethnic patterns of childhood nephrotic syndrome in Yorkshire, UK. Pediatr Nephrol 2001;16:1040-4. doi:10. 1007/ s004670100021
2. International Study of Kidney Disease in Children. Nephrotic syndrome in children: prediction of histopathology from clinical and laboratory characteristics at time of diagnosis. A report of the International Study of Kidney Disease in Children. Kidney Int 1978;13:159-65. doi:10. 1038/ki. 1978. 23
3. Feehally J, Kendell NP, Swift PG, Walls J. High incidence of minimal change nephrotic syndrome in Asians. Arch Dis Child 1985;60:1018-20. doi:10. 1136/adc. 60. 11. 1018
4. Sharples PM, Poulton J, White RH. Steroid responsive nephrotic syndrome is more common in Asians. Arch Dis Child 1985;60:1014-7. doi:10. 1136/adc. 60. 11. 1014
5. Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet 1985;1:368-70. doi:10. 1016/S0140-6736(85)91387-X
6. Webb NJA. Steroid sensitive nephrotic syndrome. In Pediatric Nephrology 2nd Edition. Ed Rees L, Brogan PA, Bockenhauer D, Webb NJA. Oxford University Press 2012.
7. Larkins N, Kim S, Craig J, Hodson E. Steroid-sensitive nephrotic syndrome: An evidence-based update of immunosuppressive treatment in children. Arch Dis Child 2016;101:404-8. doi:10. 1136/ archdischild-2015-308924
8. McCaffrey J, Lennon R, Webb NJ. The non-immunosuppressive management of childhood nephrotic syndrome. Pediatr Nephrol 2016;31:1383-402. doi:10. 1007/s00467-015-3241-0
9. Abramowicz M, Barnett HL, Edelmann CMJr, et al. Controlled trial of azathioprine in children with nephrotic syndrome. A report for the international study of kidney disease in children. Lancet 1970;1:959-61. doi:10. 1016/S0140-6736(70)91093-7
10. Ehrich JH, Brodehl J. Long versus standard prednisone therapy for initial treatment of idiopathic nephrotic syndrome in children. Arbeitsgemeinschaft für Pädiatrische Nephrologie. Eur J Pediatr 1993;152:357-61. doi:10. 1007/BF01956754
11. Bagga A, Hari P, Srivastava RN. Prolonged versus standard prednisolone therapy for initial episode of nephrotic syndrome. Pediatr Nephrol 1999;13:824-7. doi:10. 1007/s004670050708
12. Jayantha UK. Comparison of ISKDC regime with a 7 months steroid regime in the first attack of nephrotic syndrome[abstract]. Pediatr Nephrol 2004;19:C81.
13. Ksiazek J, Wyszy?ska T. Short versus long initial prednisone treatment in steroid-sensitive nephrotic syndrome in children. Acta Paediatr 1995;84:889-93. doi:10. 1111/j. 1651-2227. 1995. tb13787. x
14. Norero C, Delucchi A, Lagos E, Rosati P, Chilean Co-operative Group of Study of Nephrotic Syndrome in Children. [Initial therapy of primary nephrotic syndrome in children: evaluation in a period of 18 months of two prednisone treatment schedules]. Rev Med Chil 1996;124:567-72.
15. Ueda N, Chihara M, Kawaguchi S, et al. Intermittent versus long-term tapering prednisolone for initial therapy in children with idiopathic nephrotic syndrome. J Pediatr 1988;112:122-6. doi:10. 1016/ S0022-3476(88)80136-7
16. Hodson EM, Knight JF, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev 2005;(1):CD001533.
17. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerulonephritis Work Group. KDIGO Clinical Practice Guideline for Glomerulonephritis. Kidney Int 2012;2:139-274.
18. Achenbach TM, Edelbrock CS. Manual for the child behavior checklist and revised behavior profile. University of Vermont Department of Psychiatry, 1983.
19. Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4. 0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr 2003;3:329-41. doi:10. 1367/1539-4409 (2003)003<0329:TPAAPP<2. 0. CO;2
20. Stevens K. Valuation of the Child Health Utility 9D Index. Pharmacoeconomics 2012;30:729-47. doi:10. 2165/11599120-000000000-00000
21. Macneill V, Nwokoro C, Griffiths C, Grigg J, Seale C. Recruiting ethnic minority participants to a clinical trial: A qualitative study. BMJ Open 2013;3:e002750. doi:10. 1136/bmjopen-2013-002750
22. Yoshikawa N, Nakanishi K, Sako M, et al, Japanese Study Group of Kidney Disease in Children. A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment. Kidney Int 2015;87:225-32. doi:10. 1038/ki. 2014. 260
23. Sinha A, Saha A, Kumar M, et al. Extending initial prednisolone treatment in a randomized control trial from 3 to 6 months did not significantly influence the course of illness in children with steroid-sensitive nephrotic syndrome. Kidney Int 2015;87:217-24. doi:10. 1038/ki. 2014. 240
24. Yap HK, Han EJ, Heng CK, Gong WK. Risk factors for steroid dependency in children with idiopathic nephrotic syndrome. Pediatr Nephrol 2001;16:1049-52. doi:10. 1007/s004670100024
25. Takeda A, Takimoto H, Mizusawa Y, Simoda M. Prediction of subsequent relapse in children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol 2001;16:888-93. doi:10. 1007/s004670100683
26. Anonymous. Short versus standard prednisone therapy for initial treatment of idiopathic nephrotic syndrome in children. Arbeitsgemeinschaft für Pädiatrische Nephrologie. Lancet 1988;1:380-3.