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Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

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ClinicalTrials.gov Identifier: NCT01616446
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):
Luciana dos Santos Henriques, University of Sao Paulo

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.

Condition or disease
Nephrotic Syndrome

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 : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2007
Primary Completion Date : August 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Nephrotic patients in remission
Nephrotic patients in recidive

Biospecimen Retention:   Samples Without DNA
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616446

Universidade de Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo

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
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: May 2012

Keywords provided by Luciana dos Santos Henriques, University of Sao Paulo:
nephrotic syndrome

Additional relevant MeSH terms:
Nephrotic Syndrome
Pathologic Processes
Kidney Diseases
Urologic Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors