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
  Purpose

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.


Condition
Nephrotic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Biospecimen Retention:   Samples Without DNA

Whole blood


Enrollment: 10
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
remission
Nephrotic patients in remission
relapse
Nephrotic patients in recidive

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616446

Locations
Brazil
Universidade de Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luciana dos Santos Henriques, principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01616446     History of Changes
Other Study ID Numbers: CLINICS-D-12-00179R1
Study First Received: June 7, 2012
Last Updated: June 8, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
cyclosporin
nephrotic syndrome
pharmacokinetics
children

Additional relevant MeSH terms:
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014