Pharmacokinetics of Cyclosporin in Nephrotic Syndrome
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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 |
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 |
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
Contacts and Locations 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:
|
Nephrosis, Lipoid 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 May 19, 2013