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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 7, 2012
Last Updated Date	June 8, 2012
Start Date ^ICMJE	February 2007
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01616446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics of Cyclosporin in Nephrotic Syndrome
Official Title ^ICMJE	PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Whole blood
Sampling Method	Non-Probability Sample
Study Population	Children with Iidiopathic nephrotic syndrome followed in the Pediatric Nephrology Unit of Instituto da Criança-HCFMUSP
Condition ^ICMJE	Nephrotic Syndrome
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	remission Nephrotic patients in remission relapse Nephrotic patients in recidive
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	10
Completion Date	February 2010
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	1 Year to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01616446
Other Study ID Numbers ^ICMJE	CLINICS-D-12-00179R1
Has Data Monitoring Committee	No
Responsible Party	Luciana dos Santos Henriques, University of Sao Paulo
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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