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Erschienen in: Pediatric Nephrology 12/2023

10.01.2023 | Educational Review

The first randomized controlled trial in pediatric nephrology: the history of the International Study of Kidney Disease in Children (ISKDC)

verfasst von: William A. Primack, Robert L. Chevalier, Aaron Friedman, Kevin V. Lemley, Victoria F. Norwood, George J. Schwartz, Douglas Silverstein, Frederick Kaskel

Erschienen in: Pediatric Nephrology | Ausgabe 12/2023

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Abstract

The International Study of Kidney Disease in Children (ISKDC), begun in 1966, conducted the first international collaborative randomized blinded controlled trial in pediatric nephrology and one of the first in either pediatrics or nephrology. For this trial, the ISKDC developed the criteria, such as those for response and relapse, used today to describe the clinical course of the nephrotic syndrome, and the trial generated the nephropathologic terminology and criteria which largely remain the current standards. Over an approximately 20-year span, the ISKDC followed the natural history and evaluated the therapeutic effectiveness of therapies in over 500 children with the nephrotic syndrome from three continents. It published 14 peer-reviewed studies and several reports and commentaries, many of which helped create current standards of practice for therapy of childhood nephrotic syndrome and consequently remain highly cited today. The ISKDC continues to be an important model for subsequent collaborative studies and was the impetus for the development of regional and national pediatric nephrology societies leading to the recognition and growth of pediatric nephrology as a separate subspecialty.

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Literatur
1.
Zurück zum Zitat Barnett H (1984) Philosophy and ethics of multicenter international controlled clinical trials in children. In: Brodehl J, Ehrich JHH (eds) Pediatric Nephrology. Springer Verlag, Berlin, pp 30–35CrossRef Barnett H (1984) Philosophy and ethics of multicenter international controlled clinical trials in children. In: Brodehl J, Ehrich JHH (eds) Pediatric Nephrology. Springer Verlag, Berlin, pp 30–35CrossRef
6.
Zurück zum Zitat Barnett HL, McNamara H, McCrory W, Forman C, Rapoport M, Michie A, Barbero G (1950) The effects of ACTH and cortisone on the nephrotic syndrome. AMA Am J Dis Child 80:519–520PubMed Barnett HL, McNamara H, McCrory W, Forman C, Rapoport M, Michie A, Barbero G (1950) The effects of ACTH and cortisone on the nephrotic syndrome. AMA Am J Dis Child 80:519–520PubMed
9.
Zurück zum Zitat Kohn JL, Gribetz D (1960) Nephrotic syndrome of childhood. Comparison of results of current hormonal therapy with those achieved previously. Am J Dis Child 100:373–376CrossRefPubMed Kohn JL, Gribetz D (1960) Nephrotic syndrome of childhood. Comparison of results of current hormonal therapy with those achieved previously. Am J Dis Child 100:373–376CrossRefPubMed
11.
Zurück zum Zitat (1978) 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 13:159–165. https://doi.org/10.1038/ki.1978.23 (1978) 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 13:159–165. https://​doi.​org/​10.​1038/​ki.​1978.​23
12.
Zurück zum Zitat Rovin BH, Adler SG, Barratt J, Bridoux F, Burdge KA, Chan TM, Cook HT, Fervenza FC, Gibson KL, Glassock RJ, Jayne DRW, Jha V, Liew A, Liu ZH, Mejía- Vilet JM, Nester CM, Radhakrishnan J, Rave EM, Reich HN, Ronco P, Sanders JF, Sethi S, Suzuki Y, Tang SCW, Tesar V, Vivarelli M, Wetzels JFM, Lytvyn L, Craig JC, Tunnicliffe DJ, Howell M, Tonelli MA, Cheung M, Earley A, Floege J (2021) Executive summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases. Kidney Int 100:753–779. https://doi.org/10.1016/j.kint.2021.05.015CrossRefPubMed Rovin BH, Adler SG, Barratt J, Bridoux F, Burdge KA, Chan TM, Cook HT, Fervenza FC, Gibson KL, Glassock RJ, Jayne DRW, Jha V, Liew A, Liu ZH, Mejía- Vilet JM, Nester CM, Radhakrishnan J, Rave EM, Reich HN, Ronco P, Sanders JF, Sethi S, Suzuki Y, Tang SCW, Tesar V, Vivarelli M, Wetzels JFM, Lytvyn L, Craig JC, Tunnicliffe DJ, Howell M, Tonelli MA, Cheung M, Earley A, Floege J (2021) Executive summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases. Kidney Int 100:753–779. https://​doi.​org/​10.​1016/​j.​kint.​2021.​05.​015CrossRefPubMed
15.
Zurück zum Zitat Drummond KN, Hillman DA, Marchessault JH, Feldman W (1968) Cyclophosphamide in the nephrotic syndrome of childhood: its use in two groups of patients defined by clinical, light microscopic and immunopathologic findings. Can Med Assoc J 98:524–531PubMedPubMedCentral Drummond KN, Hillman DA, Marchessault JH, Feldman W (1968) Cyclophosphamide in the nephrotic syndrome of childhood: its use in two groups of patients defined by clinical, light microscopic and immunopathologic findings. Can Med Assoc J 98:524–531PubMedPubMedCentral
17.
Zurück zum Zitat Adams DA, Gordon A, Maxwell MH (1967) Azathioprine treatment of immunological renal disease. JAMA 199:459–463CrossRefPubMed Adams DA, Gordon A, Maxwell MH (1967) Azathioprine treatment of immunological renal disease. JAMA 199:459–463CrossRefPubMed
18.
Zurück zum Zitat Barnett HL (1979) International study of kidney disease in children. Nihon Jinzo Gakkai Shi 21:1141–1144PubMed Barnett HL (1979) International study of kidney disease in children. Nihon Jinzo Gakkai Shi 21:1141–1144PubMed
19.
Zurück zum Zitat Spitzer A (1977) Ten years of activity: A report for the International Study of kidney Disease in Children. In: Kluthe R, Vogt A, Botsford (eds) Glomerulonephritis. Wiley, New York, pp 201–210 Spitzer A (1977) Ten years of activity: A report for the International Study of kidney Disease in Children. In: Kluthe R, Vogt A, Botsford (eds) Glomerulonephritis. Wiley, New York, pp 201–210
24.
Zurück zum Zitat (1974) Prospective controlled trial of cyclophosphamide therapy in children with nephrotic syndrome Report of the International Study of Kidney Disease in Children. Lancet 2:423–427 (1974) Prospective controlled trial of cyclophosphamide therapy in children with nephrotic syndrome Report of the International Study of Kidney Disease in Children. Lancet 2:423–427
27.
Zurück zum Zitat ISKDC (1972) International workshop on risk benefit assessment of cyclophosphamide in renal disease. Kidney Int 2:352–353 ISKDC (1972) International workshop on risk benefit assessment of cyclophosphamide in renal disease. Kidney Int 2:352–353
28.
29.
Zurück zum Zitat Ehren R, Benz MR, Brinkkötter PT, Dötsch J, Eberl WR, Gellermann J, Hoyer PF, Jordans I, Kamrath C, Kemper MJ, Latta K, Müller D, Oh J, Tönshoff B, Weber S, Weber LT, German Society for Pediatric Nephrology (2021) Pediatric idiopathic steroid- sensitive nephrotic syndrome: diagnosis and therapy -short version of the updated German best practice guideline (S2e) - AWMF register no. 166–001, 6/2020. Pediatr Nephrol 36:2971–2985. https://doi.org/10.1007/s00467-021-05135-3CrossRefPubMedPubMedCentral Ehren R, Benz MR, Brinkkötter PT, Dötsch J, Eberl WR, Gellermann J, Hoyer PF, Jordans I, Kamrath C, Kemper MJ, Latta K, Müller D, Oh J, Tönshoff B, Weber S, Weber LT, German Society for Pediatric Nephrology (2021) Pediatric idiopathic steroid- sensitive nephrotic syndrome: diagnosis and therapy -short version of the updated German best practice guideline (S2e) - AWMF register no. 166–001, 6/2020. Pediatr Nephrol 36:2971–2985. https://​doi.​org/​10.​1007/​s00467-021-05135-3CrossRefPubMedPubMedCentral
30.
Zurück zum Zitat Churg J, Duffy JL, Bernstein J (1979) Identification of dense deposit disease: a report for the International Study of Kidney Diseases in Children. Arch Pathol Lab Med 103:67–72PubMed Churg J, Duffy JL, Bernstein J (1979) Identification of dense deposit disease: a report for the International Study of Kidney Diseases in Children. Arch Pathol Lab Med 103:67–72PubMed
31.
Zurück zum Zitat (1981) Primary nephrotic syndrome in children: clinical significance of histopathologic variants of minimal change and of diffuse mesangial hypercellularity. A Report of the International Study of Kidney Disease in Children. Kidney Int 20:765–771. https://doi.org/10.1038/ki.1981.209 (1981) Primary nephrotic syndrome in children: clinical significance of histopathologic variants of minimal change and of diffuse mesangial hypercellularity. A Report of the International Study of Kidney Disease in Children. Kidney Int 20:765–771. https://​doi.​org/​10.​1038/​ki.​1981.​209
37.
Zurück zum Zitat Working Group of the International IgA Nephropathy Network and the Renal Pathology Society, Cattran DC, Coppo R, Cook HT, Feehally J, Roberts IS, Troyanov S, Alpers CE, Amore A, Barratt J, Berthoux F, Bonsib S, Bruijn JA, D’Agati V, D’Amico G, Emancipator S, Emma F, Ferrario F, Fervenza FC, Florquin S, Fogo A, Geddes CC, Groene HJ, Haas M, Herzenberg AM, Hill PA, Hogg RJ, Hsu SI, Jennette JC, Joh K, Julian BA, Kawamura T, Lai FM, Leung CB, Li LS, Li PK, Liu ZH, Mackinnon B, Mezzano S, Schena FP, Tomino Y, Walker PD, Wang H, Weening JJ, Yoshikawa N, Zhang H (2009) The Oxford classification of IgA nephropathy: rationale, clinicopathological correlations, and classification. Kidney Int 76:534–545. https://doi.org/10.1038/ki.2009.243CrossRef Working Group of the International IgA Nephropathy Network and the Renal Pathology Society, Cattran DC, Coppo R, Cook HT, Feehally J, Roberts IS, Troyanov S, Alpers CE, Amore A, Barratt J, Berthoux F, Bonsib S, Bruijn JA, D’Agati V, D’Amico G, Emancipator S, Emma F, Ferrario F, Fervenza FC, Florquin S, Fogo A, Geddes CC, Groene HJ, Haas M, Herzenberg AM, Hill PA, Hogg RJ, Hsu SI, Jennette JC, Joh K, Julian BA, Kawamura T, Lai FM, Leung CB, Li LS, Li PK, Liu ZH, Mackinnon B, Mezzano S, Schena FP, Tomino Y, Walker PD, Wang H, Weening JJ, Yoshikawa N, Zhang H (2009) The Oxford classification of IgA nephropathy: rationale, clinicopathological correlations, and classification. Kidney Int 76:534–545. https://​doi.​org/​10.​1038/​ki.​2009.​243CrossRef
42.
Zurück zum Zitat Yoshikawa N, Nakanishi K, Sako M, Oba MS, Mori R, Ota E, Ishikura K, Hataya H, Honda M, Ito S, Shima Y, Kaito H, Nozu K, Nakamura H, Igarashi T, Ohashi Y, Iijima K (2015) 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 87:225–232. https://doi.org/10.1038/ki.2014.260CrossRefPubMed Yoshikawa N, Nakanishi K, Sako M, Oba MS, Mori R, Ota E, Ishikura K, Hataya H, Honda M, Ito S, Shima Y, Kaito H, Nozu K, Nakamura H, Igarashi T, Ohashi Y, Iijima K (2015) 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 87:225–232. https://​doi.​org/​10.​1038/​ki.​2014.​260CrossRefPubMed
43.
Zurück zum Zitat Pasini A, Bertulli C, Casadio L, Corrado C, Edefonti A, Ghiggeri G, Ghio L, Giordano M, La Scola C, Malaventura C, Maringhini S, Mastrangelo AP, Materassi M, Mencarelli F, Messina G, Monti E, Morello W, Puccio G, Romagnani P, Montini G, NefroKid Study Group (2021) Childhood idiopathic nephrotic syndrome: does the initial steroid treatment modify the outcome? A multicentre, prospective cohort study. Front Pediatr 9:627–636. https://doi.org/10.3389/fped.2021.627636CrossRef Pasini A, Bertulli C, Casadio L, Corrado C, Edefonti A, Ghiggeri G, Ghio L, Giordano M, La Scola C, Malaventura C, Maringhini S, Mastrangelo AP, Materassi M, Mencarelli F, Messina G, Monti E, Morello W, Puccio G, Romagnani P, Montini G, NefroKid Study Group (2021) Childhood idiopathic nephrotic syndrome: does the initial steroid treatment modify the outcome? A multicentre, prospective cohort study. Front Pediatr 9:627–636. https://​doi.​org/​10.​3389/​fped.​2021.​627636CrossRef
44.
Zurück zum Zitat Gadegbeku CA, Gipson DS, Holzman LB, Ojo AO, Song PX, Barisoni L, Sampson MG, Kopp JB, Lemley KV, Nelson PJ, Lienczewski CC, Adler SG, Appel GB, Cattran DC, Choi MJ, Contreras G, Dell KM, Fervenza FC, Gibson KL, Greenbaum LA, Hernandez JD, Hewitt SM, Hingorani SR, Hladunewich M, Hogan MC, Hogan SL, Kaskel FJ, Lieske JC, Meyers KE, Nachman PH, Nast CC, Neu AM, Reich HN, Sedor JR, Sethna CB, Trachtman H, Tuttle KR, Zhdanova O, Zilleruelo GE, Kretzler M (2013) Design of the Nephrotic Syndrome Study Network (NEPTUNE) to evaluate primary glomerular nephropathy by a multidisciplinary approach. Kidney Int 83:749–756. https://doi.org/10.1038/ki.2012.428CrossRefPubMedPubMedCentral Gadegbeku CA, Gipson DS, Holzman LB, Ojo AO, Song PX, Barisoni L, Sampson MG, Kopp JB, Lemley KV, Nelson PJ, Lienczewski CC, Adler SG, Appel GB, Cattran DC, Choi MJ, Contreras G, Dell KM, Fervenza FC, Gibson KL, Greenbaum LA, Hernandez JD, Hewitt SM, Hingorani SR, Hladunewich M, Hogan MC, Hogan SL, Kaskel FJ, Lieske JC, Meyers KE, Nachman PH, Nast CC, Neu AM, Reich HN, Sedor JR, Sethna CB, Trachtman H, Tuttle KR, Zhdanova O, Zilleruelo GE, Kretzler M (2013) Design of the Nephrotic Syndrome Study Network (NEPTUNE) to evaluate primary glomerular nephropathy by a multidisciplinary approach. Kidney Int 83:749–756. https://​doi.​org/​10.​1038/​ki.​2012.​428CrossRefPubMedPubMedCentral
45.
Zurück zum Zitat Mariani LH, Bomback AS, Canetta PA, Flessner MF, Helmuth M, Hladunewich MA, Hogan JJ, Kiryluk K, Nachman PH, Nast CC, Rheault MN, Rizk DV, Trachtman H, Wenderfer SE, Bowers C, Hill-Callahan P, Marasa M, Poulton CJ, Revell A, Vento S, Barisoni L, Cattran D, D’Agati V, Jennette JC, Klein JB, Laurin LP, Twombley K, Falk RJ, Gharavi AG, Gillespie BW, Gipson DS, Greenbaum LA, Holzman LB, Kretzler M, Robinson B, Smoyer WE, Guay-Woodford LM, CureGN Consortium (2019) CureGN study rationale, design, and methods: establishing a large prospective observational study of glomerular disease. Am J Kidney Dis 73:218–229. https://doi.org/10.1053/j.ajkd.2018.07.020CrossRefPubMed Mariani LH, Bomback AS, Canetta PA, Flessner MF, Helmuth M, Hladunewich MA, Hogan JJ, Kiryluk K, Nachman PH, Nast CC, Rheault MN, Rizk DV, Trachtman H, Wenderfer SE, Bowers C, Hill-Callahan P, Marasa M, Poulton CJ, Revell A, Vento S, Barisoni L, Cattran D, D’Agati V, Jennette JC, Klein JB, Laurin LP, Twombley K, Falk RJ, Gharavi AG, Gillespie BW, Gipson DS, Greenbaum LA, Holzman LB, Kretzler M, Robinson B, Smoyer WE, Guay-Woodford LM, CureGN Consortium (2019) CureGN study rationale, design, and methods: establishing a large prospective observational study of glomerular disease. Am J Kidney Dis 73:218–229. https://​doi.​org/​10.​1053/​j.​ajkd.​2018.​07.​020CrossRefPubMed
46.
Zurück zum Zitat Trautmann A, Bodria M, Ozaltin F, Gheisari A, Melk A, Azocar M, Anarat A, Caliskan S, Emma F, Gellermann J, Oh J, Baskin E, Ksiazek J, Remuzzi G, Erdogan O, Akman S, Dusek J, Davitaia T, Özkaya O, Papachristou F, Firszt-Adamczyk A, Urasinski T, Testa S, Krmar RT, Hyla-Klekot L, Pasini A, Özcakar ZB, Sallay P, Cakar N, Galanti M, Terzic J, Aoun B, Caldas Afonso A, Szymanik-Grzelak H, Lipska BS, Schnaidt S, Schaefer F, PodoNet Consortium (2015) Spectrum of steroid- resistant and congenital nephrotic syndrome in children: the PodoNet registry cohort. Clin J Am Soc Nephrol 10:592–600. https://doi.org/10.2215/CJN.06260614CrossRefPubMedPubMedCentral Trautmann A, Bodria M, Ozaltin F, Gheisari A, Melk A, Azocar M, Anarat A, Caliskan S, Emma F, Gellermann J, Oh J, Baskin E, Ksiazek J, Remuzzi G, Erdogan O, Akman S, Dusek J, Davitaia T, Özkaya O, Papachristou F, Firszt-Adamczyk A, Urasinski T, Testa S, Krmar RT, Hyla-Klekot L, Pasini A, Özcakar ZB, Sallay P, Cakar N, Galanti M, Terzic J, Aoun B, Caldas Afonso A, Szymanik-Grzelak H, Lipska BS, Schnaidt S, Schaefer F, PodoNet Consortium (2015) Spectrum of steroid- resistant and congenital nephrotic syndrome in children: the PodoNet registry cohort. Clin J Am Soc Nephrol 10:592–600. https://​doi.​org/​10.​2215/​CJN.​06260614CrossRefPubMedPubMedCentral
47.
Zurück zum Zitat Trautmann A, Vivarelli M, Samuel S, Gipson D, Sinha A, Schaefer F, Hui NK, Boyer O, Saleem MA, Feltran L, Müller-Deile J, Becker JU, Cano F, Xu H, Lim YN, Smoyer W, Anochie I, Nakanishi K, Hodson E, Haffner D, International Pediatric Nephrology Association (2020) IPNA clinical practice recommendations for the diagnosis and management of children with steroid-resistant nephrotic syndrome. Pediatr Nephrol 35:1529–1561. https://doi.org/10.1007/s00467-020-04519-1CrossRefPubMedPubMedCentral Trautmann A, Vivarelli M, Samuel S, Gipson D, Sinha A, Schaefer F, Hui NK, Boyer O, Saleem MA, Feltran L, Müller-Deile J, Becker JU, Cano F, Xu H, Lim YN, Smoyer W, Anochie I, Nakanishi K, Hodson E, Haffner D, International Pediatric Nephrology Association (2020) IPNA clinical practice recommendations for the diagnosis and management of children with steroid-resistant nephrotic syndrome. Pediatr Nephrol 35:1529–1561. https://​doi.​org/​10.​1007/​s00467-020-04519-1CrossRefPubMedPubMedCentral
49.
Zurück zum Zitat Trautmann A, Boyer O, Hodson E, Bagga A, Gipson DS, Samuel S, Wetzels J, Alhasan K, Banerjee S, Bhimma R, Bonilla-Felix M, Cano F, Christian M, Hahn D, Kang HG, Nakanishi K, Safouh H, Trachtman H, Xu H, Cook W, Vivarelli M, Haffner D, International Pediatric Nephrology Association (2022) IPNA clinical practice recommendations for the diagnosis and management of children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol. https://doi.org/10.1007/s00467-022-05739-3CrossRefPubMedPubMedCentral Trautmann A, Boyer O, Hodson E, Bagga A, Gipson DS, Samuel S, Wetzels J, Alhasan K, Banerjee S, Bhimma R, Bonilla-Felix M, Cano F, Christian M, Hahn D, Kang HG, Nakanishi K, Safouh H, Trachtman H, Xu H, Cook W, Vivarelli M, Haffner D, International Pediatric Nephrology Association (2022) IPNA clinical practice recommendations for the diagnosis and management of children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol. https://​doi.​org/​10.​1007/​s00467-022-05739-3CrossRefPubMedPubMedCentral
56.
Zurück zum Zitat Barnett HL, Forman CW, Lauson HD (1952) The nephrotic syndrome in children. Adv Pediatr 5:53–128CrossRefPubMed Barnett HL, Forman CW, Lauson HD (1952) The nephrotic syndrome in children. Adv Pediatr 5:53–128CrossRefPubMed
Metadaten
Titel
The first randomized controlled trial in pediatric nephrology: the history of the International Study of Kidney Disease in Children (ISKDC)
verfasst von
William A. Primack
Robert L. Chevalier
Aaron Friedman
Kevin V. Lemley
Victoria F. Norwood
George J. Schwartz
Douglas Silverstein
Frederick Kaskel
Publikationsdatum
10.01.2023
Verlag
Springer Berlin Heidelberg
Erschienen in
Pediatric Nephrology / Ausgabe 12/2023
Print ISSN: 0931-041X
Elektronische ISSN: 1432-198X
DOI
https://doi.org/10.1007/s00467-022-05838-1

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