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Cyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie

First line immunosuppressive treatment in steroid-resistant nephrotic syndrome in children is still open to discussion. We conducted a controlled multicentre randomized open label trial to test the efficacy and safety of cyclosporin A (CSA) versus cyclophosphamide pulses (CPH) in the initial therapy... Full description

Journal Title: Pediatric nephrology (Berlin West), 2008-09-01, Vol.23 (9), p.1483-1493
Main Author: Plank, Christian
Other Authors: Kalb, Veronica , Hinkes, Bernward , Hildebrandt, Friedhelm , Gefeller, Olaf , Rascher, Wolfgang
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: Berlin/Heidelberg: Springer Berlin Heidelberg
ID: ISSN: 0931-041X
Link: https://www.ncbi.nlm.nih.gov/pubmed/18481113
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2730636
title: Cyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie
format: Article
creator:
  • Plank, Christian
  • Kalb, Veronica
  • Hinkes, Bernward
  • Hildebrandt, Friedhelm
  • Gefeller, Olaf
  • Rascher, Wolfgang
subjects:
  • Adolescent
  • Adrenal Cortex Hormones - therapeutic use
  • Article
  • Child
  • Child, Preschool
  • Cyclophosphamide
  • Cyclophosphamide - adverse effects
  • Cyclophosphamide - therapeutic use
  • Cyclosporin A
  • Cyclosporine - adverse effects
  • Cyclosporine - therapeutic use
  • Drug Resistance
  • Female
  • Focal segmental glomerulosclerosis
  • Follow-Up Studies
  • Genes, Wilms Tumor
  • Humans
  • Immunosuppressive Agents - therapeutic use
  • Infant
  • Intracellular Signaling Peptides and Proteins - genetics
  • Male
  • Medicine & Public Health
  • Membrane Proteins - genetics
  • Minimal change nephropathy
  • Mutation
  • Nephrology
  • Nephrotic syndrome
  • Nephrotic Syndrome - drug therapy
  • Nephrotic Syndrome - genetics
  • Original Article
  • Pediatrics
  • Urology
ispartof: Pediatric nephrology (Berlin, West), 2008-09-01, Vol.23 (9), p.1483-1493
description: First line immunosuppressive treatment in steroid-resistant nephrotic syndrome in children is still open to discussion. We conducted a controlled multicentre randomized open label trial to test the efficacy and safety of cyclosporin A (CSA) versus cyclophosphamide pulses (CPH) in the initial therapy of children with newly diagnosed primary steroid-resistant nephrotic syndrome and histologically proven minimal change disease, focal segmental glomerulosclerosis or mesangial hypercellularity. Patients in the CSA group ( n  = 15) were initially treated with 150 mg/m 2 CSA orally to achieve trough levels of 120–180 ng/ml, while patients in the CPH group ( n  = 17) received CPH pulses (500 mg/m 2 per month intravenous). All patients were on alternate prednisone therapy. Patients with proteinuria >40 mg/m 2 per hour at 12 weeks of therapy were allocated to a non-responder protocol with high-dose CSA therapy or methylprednisolone pulses. At week 12, nine of the 15 (60%) CSA patients showed at least partial remission, evidences by a reduction of proteinuria
language: eng
source:
identifier: ISSN: 0931-041X
fulltext: no_fulltext
issn:
  • 0931-041X
  • 1432-198X
url: Link


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titleCyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie
creatorPlank, Christian ; Kalb, Veronica ; Hinkes, Bernward ; Hildebrandt, Friedhelm ; Gefeller, Olaf ; Rascher, Wolfgang
creatorcontribPlank, Christian ; Kalb, Veronica ; Hinkes, Bernward ; Hildebrandt, Friedhelm ; Gefeller, Olaf ; Rascher, Wolfgang ; Arbeitsgemeinschaft für Pädiatrische Nephrologie ; for Arbeitsgemeinschaft für Pädiatrische Nephrologie
descriptionFirst line immunosuppressive treatment in steroid-resistant nephrotic syndrome in children is still open to discussion. We conducted a controlled multicentre randomized open label trial to test the efficacy and safety of cyclosporin A (CSA) versus cyclophosphamide pulses (CPH) in the initial therapy of children with newly diagnosed primary steroid-resistant nephrotic syndrome and histologically proven minimal change disease, focal segmental glomerulosclerosis or mesangial hypercellularity. Patients in the CSA group ( n  = 15) were initially treated with 150 mg/m 2 CSA orally to achieve trough levels of 120–180 ng/ml, while patients in the CPH group ( n  = 17) received CPH pulses (500 mg/m 2 per month intravenous). All patients were on alternate prednisone therapy. Patients with proteinuria >40 mg/m 2 per hour at 12 weeks of therapy were allocated to a non-responder protocol with high-dose CSA therapy or methylprednisolone pulses. At week 12, nine of the 15 (60%) CSA patients showed at least partial remission, evidences by a reduction of proteinuria <40 mg/h per m 2 . In contrast, three of the 17 (17%) CPH patients responded ( p  < 0.05, intention-to-treat). Given these results, the study was stopped, in accordance with the protocol. After 24 weeks, complete remission was reached by two of the 15 (13%) CSA and one of the 17 (5%) CPH patients ( p  = n.s.). Partial remission was achieved by seven of the 15 (46%) CSA and two of the 15 (11%) CPH patients ( p  <0.05). Five patients in the CSA group and 14 patients in the CPH group were withdrawn from the study, most of them during the non-responder protocol. The number of adverse events was comparable between both groups. We conclude that CSA is more effective than CPH in inducing at least partial remission in steroid-resistant nephrotic syndrome in children.
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subjectAdolescent ; Adrenal Cortex Hormones - therapeutic use ; Article ; Child ; Child, Preschool ; Cyclophosphamide ; Cyclophosphamide - adverse effects ; Cyclophosphamide - therapeutic use ; Cyclosporin A ; Cyclosporine - adverse effects ; Cyclosporine - therapeutic use ; Drug Resistance ; Female ; Focal segmental glomerulosclerosis ; Follow-Up Studies ; Genes, Wilms Tumor ; Humans ; Immunosuppressive Agents - therapeutic use ; Infant ; Intracellular Signaling Peptides and Proteins - genetics ; Male ; Medicine & Public Health ; Membrane Proteins - genetics ; Minimal change nephropathy ; Mutation ; Nephrology ; Nephrotic syndrome ; Nephrotic Syndrome - drug therapy ; Nephrotic Syndrome - genetics ; Original Article ; Pediatrics ; Urology
ispartofPediatric nephrology (Berlin, West), 2008-09-01, Vol.23 (9), p.1483-1493
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0Cyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie
1Pediatric nephrology (Berlin, West)
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descriptionFirst line immunosuppressive treatment in steroid-resistant nephrotic syndrome in children is still open to discussion. We conducted a controlled multicentre randomized open label trial to test the efficacy and safety of cyclosporin A (CSA) versus cyclophosphamide pulses (CPH) in the initial therapy of children with newly diagnosed primary steroid-resistant nephrotic syndrome and histologically proven minimal change disease, focal segmental glomerulosclerosis or mesangial hypercellularity. Patients in the CSA group ( n  = 15) were initially treated with 150 mg/m 2 CSA orally to achieve trough levels of 120–180 ng/ml, while patients in the CPH group ( n  = 17) received CPH pulses (500 mg/m 2 per month intravenous). All patients were on alternate prednisone therapy. Patients with proteinuria >40 mg/m 2 per hour at 12 weeks of therapy were allocated to a non-responder protocol with high-dose CSA therapy or methylprednisolone pulses. At week 12, nine of the 15 (60%) CSA patients showed at least partial remission, evidences by a reduction of proteinuria <40 mg/h per m 2 . In contrast, three of the 17 (17%) CPH patients responded ( p  < 0.05, intention-to-treat). Given these results, the study was stopped, in accordance with the protocol. After 24 weeks, complete remission was reached by two of the 15 (13%) CSA and one of the 17 (5%) CPH patients ( p  = n.s.). Partial remission was achieved by seven of the 15 (46%) CSA and two of the 15 (11%) CPH patients ( p  <0.05). Five patients in the CSA group and 14 patients in the CPH group were withdrawn from the study, most of them during the non-responder protocol. The number of adverse events was comparable between both groups. We conclude that CSA is more effective than CPH in inducing at least partial remission in steroid-resistant nephrotic syndrome in children.
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6Cyclophosphamide - adverse effects
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8Cyclosporin A
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11Drug Resistance
12Female
13Focal segmental glomerulosclerosis
14Follow-Up Studies
15Genes, Wilms Tumor
16Humans
17Immunosuppressive Agents - therapeutic use
18Infant
19Intracellular Signaling Peptides and Proteins - genetics
20Male
21Medicine & Public Health
22Membrane Proteins - genetics
23Minimal change nephropathy
24Mutation
25Nephrology
26Nephrotic syndrome
27Nephrotic Syndrome - drug therapy
28Nephrotic Syndrome - genetics
29Original Article
30Pediatrics
31Urology
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titleCyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie
authorPlank, Christian ; Kalb, Veronica ; Hinkes, Bernward ; Hildebrandt, Friedhelm ; Gefeller, Olaf ; Rascher, Wolfgang
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1Adrenal Cortex Hormones - therapeutic use
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13Focal segmental glomerulosclerosis
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17Immunosuppressive Agents - therapeutic use
18Infant
19Intracellular Signaling Peptides and Proteins - genetics
20Male
21Medicine & Public Health
22Membrane Proteins - genetics
23Minimal change nephropathy
24Mutation
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27Nephrotic Syndrome - drug therapy
28Nephrotic Syndrome - genetics
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30Pediatrics
31Urology
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1Kalb, Veronica
2Hinkes, Bernward
3Hildebrandt, Friedhelm
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6Arbeitsgemeinschaft für Pädiatrische Nephrologie
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0Plank, Christian
1Kalb, Veronica
2Hinkes, Bernward
3Hildebrandt, Friedhelm
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atitleCyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome—a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie
jtitlePediatric nephrology (Berlin, West)
stitlePediatr Nephrol
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date2008-09-01
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issue9
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notes
0Members of Protocol committee W. Rascher, C. Plank (Erlangen, Germany); C. Aufricht (Vienna, Austria); J.H. Ehrich (Hannover, Germany); A. Fuchshuber (Freiburg, Germany); P. Hoyer (Essen); M. Kemper (Hamburg); O. Mehls, K. Schärer, B. Tönshoff (Heidelberg, Germany); U. Querfeld (Berlin, Germany); M. Schwab (Stuttgart, Germany).
1List of contributing investigators Austria: C. Aufricht; K. Arbeiter; T. Müller; A. Grillenberg; M. Mayrhofer; R. Vargha (Vienna, Linz) Germany: U. Querfeld; J. Gellermann; D. Haffner; M. Zimmering; (Berlin), H. Bachmann; N. Matthes (Bremen); G. Kalvoda; B. Mayer; S. Nolte; I. Wülke (Dresden); F. Wegner (Düren); W. Rascher; K. Benz; K. Dittrich; J. Dötsch; K-D. Nüsken; C. Plank (Erlangen); M. Pohl; S. Jacobi; C. von Schnakenburg (Freiburg); J.D. Schwarke; T. Henne (Hamburg); D.E. Müller-Wiefel; M. Kemper; A. Link; K. Zepf; (Hamburg); J.H. Ehrich; D. Franke; J. Strehlau (Hannover); B. Tönshoff; R. Feneberg; R. Himmele (Heidelberg); P. Eggert; D. Roessner (Kiel); R. Beetz (Mainz); G. Klaus; M. Konrad (Marburg); H. Fehrenbach; D. Kleinert (Memmingen); K.G. Pistor; K. Timmermann (Moers); M. Wigger; E. Drückler; I. Franke; J. Muscheites; G. Warncke (Rostock); Mutation Analysis: F. Hildebrandt, B. Hinkes; B. Mucha; R. Ruf (Ann Arbor, USA).
abstractFirst line immunosuppressive treatment in steroid-resistant nephrotic syndrome in children is still open to discussion. We conducted a controlled multicentre randomized open label trial to test the efficacy and safety of cyclosporin A (CSA) versus cyclophosphamide pulses (CPH) in the initial therapy of children with newly diagnosed primary steroid-resistant nephrotic syndrome and histologically proven minimal change disease, focal segmental glomerulosclerosis or mesangial hypercellularity. Patients in the CSA group ( n  = 15) were initially treated with 150 mg/m 2 CSA orally to achieve trough levels of 120–180 ng/ml, while patients in the CPH group ( n  = 17) received CPH pulses (500 mg/m 2 per month intravenous). All patients were on alternate prednisone therapy. Patients with proteinuria >40 mg/m 2 per hour at 12 weeks of therapy were allocated to a non-responder protocol with high-dose CSA therapy or methylprednisolone pulses. At week 12, nine of the 15 (60%) CSA patients showed at least partial remission, evidences by a reduction of proteinuria <40 mg/h per m 2 . In contrast, three of the 17 (17%) CPH patients responded ( p  < 0.05, intention-to-treat). Given these results, the study was stopped, in accordance with the protocol. After 24 weeks, complete remission was reached by two of the 15 (13%) CSA and one of the 17 (5%) CPH patients ( p  = n.s.). Partial remission was achieved by seven of the 15 (46%) CSA and two of the 15 (11%) CPH patients ( p  <0.05). Five patients in the CSA group and 14 patients in the CPH group were withdrawn from the study, most of them during the non-responder protocol. The number of adverse events was comparable between both groups. We conclude that CSA is more effective than CPH in inducing at least partial remission in steroid-resistant nephrotic syndrome in children.
copBerlin/Heidelberg
pubSpringer Berlin Heidelberg
pmid18481113
doi10.1007/s00467-008-0794-1
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