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Population pharmacokinetics and dose optimisation of colecalciferol in paediatric patients with chronic kidney

Mandy Wan1,2, Bruce Green3, Arpana Aprameya Iyengar4

  • 1Pharmacy Department, Guy's and St Thomas' NHS Foundation Trust, Evelina London Children's Hospital, London, UK.

British Journal of Clinical Pharmacology
|August 27, 2021
PubMed

Insights

This study developed a population pharmacokinetic model for colecalciferol in children with chronic kidney disease (CKD). Optimized weight-based dosing can improve vitamin D levels and reduce overdose risk in pediatric CKD patients.

Area of Science:

  • Pediatric Nephrology
  • Pharmacokinetics
  • Vitamin D Metabolism

Background:

  • High prevalence of vitamin D deficiency in pediatric chronic kidney disease (CKD).
  • Current colecalciferol dosing lacks robust pharmacokinetic (PK) data in this population.
  • Need for optimized dosing to achieve therapeutic 25-hydroxyvitamin D (25(OH)D) levels.

Purpose of the Study:

  • Develop a population PK model for colecalciferol in children with CKD.
  • Optimize colecalciferol dosing strategies for improved treatment outcomes.
  • Enhance vitamin D status in pediatric CKD patients.

Main Methods:

  • Population PK analysis using nonlinear mixed-effects modeling (NLME) on data from 83 children with CKD.
  • Investigated covariates including serum creatinine and kidney disease type.
  • Defined optimal dosing to achieve target 25(OH)D concentrations (30-48 ng/mL).

Main Results:

  • A 1-compartment model with a basal concentration parameter best described 25(OH)D time course.
  • Colecalciferol PK exhibited significant between-subject variability, with allometric weight scaling as the sole covariate.
  • Model simulations indicated current dosing can be optimized via a weight-based strategy.

Conclusions:

  • First population PK model of colecalciferol in pediatric CKD.
  • PK-informed dosing is expected to improve target 25(OH)D attainment.
  • Optimized dosing minimizes the risk of vitamin D toxicity in children with CKD.
Abstract

Keywords:
chronic kidney diseasecolecalciferolpopulation pharmacokinetics

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