TY - JOUR
T1 - A randomized clinical trial indicates that levamisole increases the time to relapse in children with steroid-sensitive idiopathic nephrotic syndrome
AU - Gruppen, Mariken P.
AU - Bouts, Antonia H.
AU - Jansen-van der Weide, Marijke C.
AU - Merkus, Maruschka P.
AU - Zurowska, Aleksandra
AU - Maternik, Michal
AU - Massella, Laura
AU - Emma, Francesco
AU - Niaudet, Patrick
AU - Cornelissen, Elisabeth A.M.
AU - Schurmans, Thierry
AU - Raes, Ann
AU - van de Walle, Johan
AU - van Dyck, Mieke
AU - Gulati, Ashima
AU - Bagga, Arvind
AU - Davin, Jean Claude
AU - Davin, Jean Claude
PY - 2017/10/17
Y1 - 2017/10/17
N2 - © 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.
AB - © 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.
KW - children
KW - levamisole
KW - nephrotic syndrome
KW - randomized clinical trial
KW - steroid sensitive
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U2 - 10.1016/j.kint.2017.08.011
DO - 10.1016/j.kint.2017.08.011
M3 - Article
AN - SCOPUS:85031670959
VL - 93
SP - 375
EP - 389
JO - Kidney International
JF - Kidney International
SN - 0085-2538
IS - 2
ER -