Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

University of Sao Paulo

Status: Completed

Conditions: Nephrotic Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01616446

CLINICS-D-12-00179R1

Details and patient eligibility

About

The purpose of this study is to evaluate whether there are differences in the pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease in children.

Full description

This is a prospective study on ten children using Cyclosporin-A (CSA) microemulsion to treat idiopathic nephrotic syndrome (INS), with normal renal function, who achieved complete remission with CSA. The objective is to compare the pharmacokinetic (PK) parameters of CSA in INS during remission and relapse of the disease. The PK profile of CSA was evaluated with the 12-hour area under the time-concentration curve (AUC0-12) using seven time-point samples. This procedure was done on each patient during remission and relapse with the same CSA dose in mg/kg/day. The AUC0-12 was calculated by trapezoidal rule. All PK parameters and the resumed 4-hour area under the time-concentration curve (AUC0-4) were correlated with AUC0-12. This study is very important because the cyclosporin is a nephrotoxic drug with narrow therapeutic window.

Enrollment: 10 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with steroid-resistant nephrotic syndrome and steroid-dependent nephrotic syndrome in use of cyclosporine
• renal function evaluated by creatinine clearance estimated by stature ≥ 90 ml/min/1.73m2
• cyclosporine trough level (C0) between 50 and 150 ng/ml
• complete remission with cyclosporine according to the guidelines of International Society of Kidney Diseases in Children

Exclusion criteria

• renal and hepatic function abnormalities
• presence of infectious disease
• clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance

Trial design

10 participants in 2 patient groups

remission

Description:

Nephrotic patients in remission

relapse

Description:

Nephrotic patients in recidive