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Population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome
A R Kreeftmeijer-Vegter1,2, T P C Dorlo1,3, M P Gruppen4
1Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, P.O. Box 80 082, 3508 TB, Utrecht, the Netherlands.
Insights
This study presents the first population pharmacokinetics of levamisole in children with nephrotic syndrome. Levamisole
Area of Science:
- Pharmacokinetics
- Pediatric Nephrology
- Drug Metabolism
Background:
- Steroid-sensitive nephrotic syndrome (SSNS) is a common kidney disease in children.
- Levamisole is an immunomodulatory drug used in some SSNS cases.
- Understanding levamisole pharmacokinetics in children is crucial for optimizing treatment.
Purpose of the Study:
- To determine the population pharmacokinetics of levamisole in children with SSNS.
- To identify factors influencing levamisole disposition in this pediatric population.
- To establish a pharmacokinetic model for levamisole in pediatric SSNS.
Main Methods:
- Non-linear mixed effects modeling was used.
- Analysis of 136 plasma samples from 38 children in a randomized controlled trial.
- A one-compartment model was applied to describe levamisole pharmacokinetics.
Main Results:
- Apparent clearance (CL/F) was 44 L/h/70kg and distribution volume (V/F) was 236 L/70kg.
- Age significantly affected clearance (-10.1% per year), but gender, tablet strength, and study center did not.
- Median Cmax was 438.3 ng/mL and AUC was 2847 ng*h/mL.
Conclusions:
- This is the first pharmacokinetic data for levamisole in children with SSNS.
- Levamisole's pharmacokinetic profile in children is similar to adults, with a slightly higher elimination rate.
- The findings support individualized dosing strategies for levamisole in pediatric SSNS.
Aim:
The aim was to investigate the population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome.
Methods:
Non-linear mixed effects modelling was performed on samples collected during a randomized controlled trial. Samples were collected from children who were receiving 2.5 mg kg(-1) levamisole (or placebo) orally once every other day. One hundred and thirty-six plasma samples were collected from 38 children from India and Europe and included in the analysis. A one compartment model described the data well.
Results:
The apparent clearance rate (CL/F) and distribution volume (V/F) were 44 l h(-1) 70 kg(-1) and 236 l 70 kg(-1) , respectively; estimated interindividual variability was 32-42%. In addition to allometric scaling of CL/F and V/F to body weight, we identified a significant proportional effect of age on CL/F (-10.1% per year). The pharmacokinetics parameters were not affected by gender, tablet strength or study centre. The median (interquartile range) maximum plasma concentration of levamisole was 438.3 (316.5-621.8) ng ml(-1) , and the median area under the concentration-time curve was 2847 (2267-3761) ng ml(-1) h. Median tmax and t½ values were 1.65 (1.32-2.0) h and 2.60 (2.06-3.65) h, respectively.
Conclusions:
Here, we present the first pharmacokinetic data regarding levamisole in children with steroid-sensitive nephrotic syndrome. The pharmacokinetic profile of levamisole in children was similar to findings reported in adults, although the elimination rate was slightly higher in children.
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