All issues > Volume 47(2); 2004

Original Article

Korean J Pediatr. 2004;47(2):193-203. Published online February 15, 2004.

Pharmacokinetics of Cyclosporine A and Its Therapeutic Effect in Children with Renal Diseases

Woo Sung WS Chun¹, Min-Soo MS Park¹, Jae Seung JS Lee¹, Juyun JY Yu², Moon Sung MS Park², Ki-Soo KS Pa²

¹Department of Pediatirics, College of Medicine, Yonsei University, Seoul, Korea
²Department of Pediatirics, School of Medicine, Ajou University, Suwon, Korea

Correspondence Ki-Soo KS Pa ,Email: kisoopai@ajou.ac.kr

Abstract

Purpose
: To know the body handling properties and anti-proteinuric effect of cyclosporine A(CsA) in children with renal diseases, 34 patients with nephrotic syndrome or glomerular diseases were included to treatment trials and evaluated.
Methods
: Microemulsion formula CsA, 5 mg/kg/day was administered orally in two divided doses for 9.3?.6 months. Pharmacokinetic studies of CsA were done twice at beginning and closing of 12 months' CsA therapy.
Results
: The steady state CsA pharmacokinetic parameters of 34 patients were as follows; Tmax : 1.64?.84 hr, Cmax : 788?54 ng/dL, C12 : 58.7?3.2 ng/mL, Cavg : 246?6 ng/mL, AUC : 2,949?,156 ng hr/mL, Vd : 4.03?.45 L/kg, CL : 9.69?.27 L/hr, T1/2 : 5.31?.37 hr. C2 was the best to predict the CsA AUC(R=0.896, P<0.001). Body surface area based dosage(mg/m2/d) correlates best with AUC. Intra-individual CsA pharmacokinetic changes were not found after 12 months' therapy. Anti- proteinuric effect of CsA was considerable; 88.9% of primary nephrotic syndrome and 62.5% of secondary glomerular diseases was responsive to CsA thearpy. There was no serious complication and CsA treatment was well tolerated by the pediatric patients.
Conclusion
: CsA therapy for difficult renal diseases with proteinuria was effective and safe. For better AUC prediction of CsA, body surface area based dosage(mg/m2/d) and C2 monitoring are recommended in children with renal diseases.

Keywords :Cyclosporine A, Pharmacokinetics, Nephrotic syndrome, Glomerular diseases, AUC(area under the time-concentration curve), Body surface area based dosage(mg/m2/d), C2 monitoring, Anti-proteinuric effect