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Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luciana dos Santos Henriques, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01616446
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: May 2012

June 7, 2012
June 8, 2012
February 2007
August 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01616446 on ClinicalTrials.gov Archive Site
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Not Provided
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Pharmacokinetics of Cyclosporin in Nephrotic Syndrome
PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood

Non-Probability Sample

Children with Iidiopathic nephrotic syndrome followed in the Pediatric Nephrology Unit of Instituto da Criança-HCFMUSP

Nephrotic Syndrome
Not Provided
  • remission
    Nephrotic patients in remission
  • relapse
    Nephrotic patients in recidive
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
February 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01616446
CLINICS-D-12-00179R1
No
Luciana dos Santos Henriques, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP