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A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome

(2018) KIDNEY INTERNATIONAL. 93(2). p.510-518
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IWT SBO 130033: SAFE-PEDRUG: Integrating multidisciplinary translational bottom-up approaches towards a new paradigm for paedriatic investigations: the next step in ethical paediatric drug research
Abstract
Levamisole has been considered the least toxic and least expensive steroid-sparing drug for preventing relapses of steroid-sensitive idiopathic nephrotic syndrome (SSINS). However, evidence for this is limited as previous randomized clinical trials were found to have methodological limitations. Therefore, we conducted an international multicenter, placebo-controlled, double-blind, randomized clinical trial to reassess its usefulness in prevention of relapses in children with SSINS. The efficacy and safety of one year of levamisole treatment in children with SSINS and frequent relapses were evaluated. The primary analysis cohort consisted of 99 patients from 6 countries. Between 100 days and 12 months after the start of study medication, the time to relapse (primary endpoint) was significantly increased in the levamisole compared to the placebo group (hazard ratio 0.22 [95% confidence interval 0.11-0.43]). Significantly, after 12 months of treatment, six percent of placebo patients versus 26 percent of levamisole patients were still in remission. During this period, the most frequent serious adverse event (four of 50 patients) possibly related to levamisole was asymptomatic moderate neutropenia, which was reversible spontaneously or after treatment discontinuation. Thus, in children with SSINS and frequent relapses, levamisole prolonged the time to relapse and also prevented recurrence during one year of treatment compared to prednisone alone. However, regular blood controls are necessary for safety issues.
Keywords
children, levamisole, nephrotic syndrome, randomized clinical trial, steroid sensitive, SUBGROUP ANALYSIS, CHILDHOOD, EFFICACY

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Citation

Please use this url to cite or link to this publication:

Chicago
Gruppen, Mariken P, Antonia H Bouts, Marijke C Jansen-van der Weide, Maruschka P Merkus, Aleksandra Zurowska, Michal Maternik, Laura Massella, et al. 2018. “A Randomized Clinical Trial Indicates That Levamisole Increases the Time to Relapse in Children with Steroid-sensitive Idiopathic Nephrotic Syndrome.” Kidney International 93 (2): 510–518.
APA
Gruppen, M. P., Bouts, A. H., Jansen-van der Weide, M. C., Merkus, M. P., Zurowska, A., Maternik, M., Massella, L., et al. (2018). A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome. KIDNEY INTERNATIONAL, 93(2), 510–518.
Vancouver
1.
Gruppen MP, Bouts AH, Jansen-van der Weide MC, Merkus MP, Zurowska A, Maternik M, et al. A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome. KIDNEY INTERNATIONAL. 2018;93(2):510–8.
MLA
Gruppen, Mariken P et al. “A Randomized Clinical Trial Indicates That Levamisole Increases the Time to Relapse in Children with Steroid-sensitive Idiopathic Nephrotic Syndrome.” KIDNEY INTERNATIONAL 93.2 (2018): 510–518. Print.
@article{8539130,
  abstract     = {Levamisole has been considered the least toxic and least expensive steroid-sparing drug for preventing relapses of steroid-sensitive idiopathic nephrotic syndrome (SSINS). However, evidence for this is limited as previous randomized clinical trials were found to have methodological limitations. Therefore, we conducted an international multicenter, placebo-controlled, double-blind, randomized clinical trial to reassess its usefulness in prevention of relapses in children with SSINS. The efficacy and safety of one year of levamisole treatment in children with SSINS and frequent relapses were evaluated. The primary analysis cohort consisted of 99 patients from 6 countries. Between 100 days and 12 months after the start of study medication, the time to relapse (primary endpoint) was significantly increased in the levamisole compared to the placebo group (hazard ratio 0.22 [95\% confidence interval 0.11-0.43]). Significantly, after 12 months of treatment, six percent of placebo patients versus 26 percent of levamisole patients were still in remission. During this period, the most frequent serious adverse event (four of 50 patients) possibly related to levamisole was asymptomatic moderate neutropenia, which was reversible spontaneously or after treatment discontinuation. Thus, in children with SSINS and frequent relapses, levamisole prolonged the time to relapse and also prevented recurrence during one year of treatment compared to prednisone alone. However, regular blood controls are necessary for safety issues.},
  author       = {Gruppen, Mariken P and Bouts, Antonia H and Jansen-van der Weide, Marijke C and Merkus, Maruschka P and Zurowska, Aleksandra and Maternik, Michal and Massella, Laura and Emma, Francesco and Niaudet, Patrick and Cornelissen, Elisabeth AM and Schurmans, Thierry and Raes, Ann and Vande Walle, Johan and van Dyck, Mieke and Gulati, Ashima and Bagga, Arvind and Davin, Jean-Claude},
  issn         = {0085-2538},
  journal      = {KIDNEY INTERNATIONAL},
  language     = {eng},
  number       = {2},
  pages        = {510--518},
  title        = {A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome},
  url          = {http://dx.doi.org/10.1016/j.kint.2017.08.011},
  volume       = {93},
  year         = {2018},
}

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