Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

NCT ID: NCT01616446

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-02-28

Brief Summary

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.

Detailed 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.

Conditions

Nephrotic Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

remission

Nephrotic patients in remission

No interventions assigned to this group

relapse

Nephrotic patients in recidive

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luciana dos Santos Henriques

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Henriques Ldos S, Matos Fde M, Vaisbich MH. Pharmacokinetics of cyclosporin--a microemulsion in children with idiopathic nephrotic syndrome. Clinics (Sao Paulo). 2012 Oct;67(10):1197-202. doi: 10.6061/clinics/2012(10)12.

Reference Type: DERIVED

PMID: 23070347 (View on PubMed)

Other Identifiers

CLINICS-D-12-00179R1

Identifier Type: -

Identifier Source: org_study_id