Pharmacokinetics of cyclosporin--a microemulsion in children with idiopathic nephrotic syndrome.
OBJECTIVE
We present a prospective study of a microemulsion of cyclosporin to treat idiopathic nephrotic syndrome in ten children with normal renal function who presented cyclosporin trough levels between 50 and 150 ng/ml and achieved complete remission with cyclosporin. To compare the pharmacokinetic parameters of cyclosporin in idiopathic nephrotic syndrome during remission and relapse of the nephrotic state.


METHODS
The pharmacokinetic profile of cyclosporin was evaluated with the 12-hour area under the time-concentration curve (auc0-12) using seven time-point samples. This procedure was performed on each patient during remission and relapse with the same cyclosporin dose in mg/kg/day. The 12-hour area under the time-concentration curve was calculated using the trapezoidal rule. All of the pharmacokinetic parameters and the resumed 4-hour area under the time-concentration curve were correlated with the 12-hour area under the time-concentration curve. ClinicalTrials.gov: NCT01616446.


RESULTS
There were no significant differences in any parameters of the pharmacokinetic of cyclosporin during remission and relapse, even when the data were normalized by dose. The best correlation with the 12-hour area under the time-concentration curve was the 4-hour area under the time-concentration curve on remission and relapse of the disease, followed by the 2-hour level after cyclosporin (c2) dosing in both disease states.


CONCLUSIONS
These data indicate that the same parameters used for cyclosporin therapeutic monitoring estimated during the nephrotic state can also be used during remission. Larger controlled studies are needed to confirm these findings.
Instituto da Criança, Faculdade de Medicina, Universidade de São Paulo, São Paulo/SP, Brazil. lushenriques@gmail.com
Luciana dos Santos
Ldos S
Henriques
Fabíola de Marcos
Fde M
Matos
Maria Helena
MH
Vaisbich
D000293:Adolescent; D019540:Area Under Curve; D002648:Child; D002675:Child, Preschool; D002784:Cholesterol / Q000097:blood; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D009404:Nephrotic Syndrome / Q000188:drug therapy / Q000378:metabolism*; D011446:Prospective Studies; D011507:Proteinuria / Q000188:drug therapy; D012709:Serum Albumin / Q000032:analysis; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D012709:Serum Albumin; D016572:Cyclosporine; D002784:Cholesterol; D003404:Creatinine