Korean J Pediatr.  2004 Feb;47(2):193-203.

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

• Chun WS
• Park MS
• Lee JS
• Yu J
• Park MS
• Pai KS

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+/-4.6 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+/-0.84 hr, Cmax:788+/-354 ng/dL, C12:58.7+/-33.2 ng/mL, Cavg:246+/-96 ng/mL, AUC:2,949+/-1,156 ng hr/mL, Vd:4.03+/-0.45 L/kg, CL:9.69+/-2.27 L/hr, T1/2:5.31+/-2.37 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.

Keyword

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

MeSH Terms

Area Under Curve
Body Surface Area
Child*
Cyclosporine*
Humans
Nephrotic Syndrome
Pharmacokinetics*
Proteinuria
Cyclosporine