Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:

PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616446
• Other study ID #: CLINICS-D-12-00179R1
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 8, 2012
• Start date: February 2007
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Locations

Country	Name	City	State
Brazil	Universidade de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil,