American Journal of Kidney Diseases
Volume 53, Issue 5 , Pages 760-769 , May 2009

Efficacy and Safety of Tacrolimus Versus Cyclosporine in Children With Steroid-Resistant Nephrotic Syndrome: A Randomized Controlled Trial

  • Swati Choudhry, MD

      Affiliations

    • Division of Nephrology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
    • ,
  • Arvind Bagga, MD

      Affiliations

    • Division of Nephrology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
    • Corresponding Author InformationAddress correspondence to Arvind Bagga, MD, Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India
    • ,
  • Pankaj Hari, MD

      Affiliations

    • Division of Nephrology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
    • ,
  • Sonika Sharma, MSc

      Affiliations

    • Division of Genetics, Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
    • ,
  • Mani Kalaivani, MSc

      Affiliations

    • Department of Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
    • ,
  • Amit Dinda, PhD

      Affiliations

    • Department of Pathology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India

Received 20 June 2008 ,Accepted 13 November 2008.

References 

  1. Bagga A, Mantan M. Nephrotic syndrome in children. Indian J Med Res. 2005;122:13–28
  2. Hodson EM, Habashy D, Craig JC. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2006;2:CD003594
  3. Tarshish P, Tobin JN, Bernstein J, Edelmann CM. Cyclophosphamide does not benefit patients with focal segmental glomerulosclerosis (A report for the International Study of Kidney Disease in Children). Pediatr Nephrol. 1996;10:590–593
  4. Prospective, controlled trial of cyclophosphamide therapy in children with the nephrotic syndrome (Report of the International Study of Kidney Disease in Children). No authors listed: Lancet. 1974;2:423–427
  5. Hari P, Bagga A, Mantan M. Short term efficacy of intravenous dexamethasone and methylprednisolone therapy in steroid resistant nephrotic syndrome. Indian Pediatr. 2004;41:993–1000
  6. Bajpai A, Bagga A, Hari P, Dinda A, Srivastava RN. Intravenous cyclophosphamide in steroid-resistant nephrotic syndrome. Pediatr Nephrol. 2003;18:351–356
  7. Niaudet P, Habib R, Tete MJ, Hinglais N, Broyer M. Cyclosporin in the treatment of idiopathic nephrotic syndrome in children. Pediatr Nephrol. 1987;1:566–573
  8. Ponticelli C, Rizzoni G, Edefonti A, et al. A randomized trial of cyclosporine in steroid-resistant idiopathic nephrotic syndrome. Kidney Int. 1993;43:1377–1384
  9. Cattran DC, Appel GB, Hebert LA, et al. A randomized trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis (North America Nephrotic Syndrome Study Group). Kidney Int. 1999;56:2220–2226
  10. Mahmoud I, Basuni F, Sabry A, et al. Single centre experience with cyclosporine in 106 children with idiopathic focal segmental glomerulosclerosis. Nephrol Dial Transplant. 2005;20:735–742
  11. Lieberman KV, Tejani A. A randomized double-blind placebo controlled trial of cyclosporine in steroid-resistant idiopathic focal segmental glomerulosclerosis in children. J Am Soc Nephrol. 1996;7:56–63
  12. Denton MD, Magee CC, Sayegh MH. Immunosuppressive strategies in transplantation. Lancet. 1999;353:1083–1091
  13. Webster A, Taylor RS, Chapman JR, Craig JC. Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev. 2005;4:CD003961
  14. McCauley J, Shapiro R, Ellis D, Igdal H, Tzakis A, Starzl TE. Pilot trial of FK-506 in the management of steroid-resistant nephrotic syndrome. Nephrol Dial Transplant. 1993;8:1286–1290
  15. Segarra A, Vila J, Pou L, et al. Combined therapy of tacrolimus and corticosteroids in cyclosporin-resistant or -dependent idiopathic focal glomerulosclerosis: A preliminary uncontrolled study with prospective follow up. Nephrol Dial Transplant. 2002;17:655–662
  16. Loeffler K, Gowrishanker M, Yiu V. Tacrolimus therapy in pediatric patients with treatment-resistant nephrotic syndrome. Pediatr Nephrol. 2004;19:281–287
  17. Schwartz GJ, Haycock GB, Edelman CM, Spitzer A. A simple measure of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976;58:259–263
  18. Srivastava RN, Bagga A. Nephrotic syndrome. In:  Srivastava RN,  Bagga A editor. Pediatric Nephrology. (ed 4). New Delhi, India: Jaypee; 2005;p. 161–200
  19. Boute N, Gribouval O, Roselli S, et al. NPHS2, encoding the glomerular protein podocin, is mutated in autosomal recessive steroid-resistant nephrotic syndrome. Nat Genet. 2000;24:349–354
  20. Mucha B, Ozaltin F, Hinkes BG, et al. Mutations in the Wilms' tumor 1 gene cause isolated steroid resistant nephrotic syndrome and occur in exons 8 and 9. Pediatr Res. 2006;59:325–331
  21. Ganguly A, Rock MJ, Prockop DJ. Conformation-sensitive gel electrophoresis for rapid detection of single-base differences in double-stranded PCR products and DNA fragments: Evidence for solvent induced bends in DNA heteroduplexes. Proc Natl Acad Sci U S A. 1993;90:10325–10329
  22. Tsukaguchi H, Sudhakar A, Le TC, et al. NPHS2 mutations in late-onset focal segmental glomerulosclerosis: R229Q is a common disease-associated allele. J Clin Invest. 2002;110:1659–1666
  23. National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The Fourth Report on the Diagnosis, Evaluation and Treatment of High Blood Pressure in Children and Adolescents. Pediatrics. 2004;114(suppl 2):S555–S576
  24. Gomez E, Sanchez-Nunez M, Sanchez JE, et al. Treatment of cyclosporin-induced gingival hyperplasia with azithromycin. Nephrol Dial Transplant. 1997;12:2694–2697
  25. Vercauteren SB, Bosmans JL, Elseviers MM, Verpooten GA, Broe ED. A meta-analysis and morphological review of cyclosporine-induced nephrotoxicity in auto-immune diseases. Kidney Int. 1998;54:536–545
  26. Ehrich JHH, Geerlings C, Zivicnjak M, Franke D, Geerlings H, Gellermann J. Steroid-resistant idiopathic childhood nephrosis: Overdiagnosed and undertreated. Nephrol Dial Transplant. 2007;22:2183–2193
  27. Bhimma R, Adhikari M, Asharam K, Connolly C. Management of steroid-resistant focal segmental glomerulosclerosis in children using tacrolimus. Am J Nephrol. 2006;26:544–551
  28. Gulati S, Prasad N, Sharma RK, Kumar A, Gupta A, Baburaj VP. Tacrolimus: A new therapy for steroid-resistant nephrotic syndrome in children. Nephrol Dial Transplant. 2008;23:910–913
  29. Ruf RG, Lichtenberger A, Karle SM, et al. Patients with mutations in NPHS2 (podocin) do not respond to standard steroid treatment of nephrotic syndrome. J Am Soc Nephrol. 2004;15:722–732
  30. Caridi G, Bertelli R, Di Duca M, et al. Broadening the spectrum of diseases related to podocin mutations. J Am Soc Nephrol. 2003;14:1278–1286
  31. Schwaderer P, Knüppel T, Konrad M, et al. Clinical course and NPHS2 analysis in patients with late steroid-resistant nephrotic syndrome. Pediatr Nephrol. 2008;23:251–256
  32. Sinha MD, MacLeod R, Rigby E, Clark AGB. Treatment of severe steroid dependent nephrotic syndrome (SDNS) in children with tacrolimus. Nephrol Dial Transplant. 2006;21:1848–1854

 Originally published online as doi:10.1053/j.ajkd.2008.11.033 on March 6, 2009.

 Trial Registration: www.cochrane-renal.org; study number: CRG030600042.

PII: S0272-6386(09)00051-1

doi: 10.1053/j.ajkd.2008.11.033

American Journal of Kidney Diseases
Volume 53, Issue 5 , Pages 760-769 , May 2009

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