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

Mariken P. Gruppen, Antonia H. Bouts, Marijke C. Jansen-van der Weide, Maruschka P. Merkus, Aleksandra Zurowska, Michal Maternik, Laura Massella, Francesco Emma, Patrick Niaudet, Elisabeth A.M. Cornelissen, Thierry Schurmans, Ann Raes, Johan van de Walle, Mieke van Dyck, Ashima Gulati, Arvind Bagga, Jean Claude Davin, Jean Claude Davin

Research output: Contribution to journalArticle

Abstract

© 2017 International Society of Nephrology 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.
Original languageEnglish
Pages (from-to)375-389
Number of pages15
JournalKidney International
Volume93
Issue number2
DOIs
Publication statusPublished - Oct 17 2017

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Keywords

  • children
  • levamisole
  • nephrotic syndrome
  • randomized clinical trial
  • steroid sensitive

Cite this

Gruppen, M. P., Bouts, A. H., Jansen-van der Weide, M. C., Merkus, M. P., Zurowska, A., Maternik, M., Massella, L., Emma, F., Niaudet, P., Cornelissen, E. A. M., Schurmans, T., Raes, A., van de Walle, J., van Dyck, M., Gulati, A., Bagga, A., Davin, J. C., & Davin, J. C. (2017). A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome. Kidney International, 93(2), 375-389. https://doi.org/10.1016/j.kint.2017.08.011