Nephrotic SyndromeNCT01616446
Pharmacokinetics of Cyclosporin in Nephrotic Syndrome
An observational study of Nephrotic Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Nephrotic Syndrome
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Iidiopathic nephrotic syndrome followed in the Pediatric Nephrology Unit of Instituto da Criança-HCFMUSP
Who may be able to join
- 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
Who cannot join
- renal and hepatic function abnormalities
- presence of infectious disease
- clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrotic Syndrome
- Keywords
- cyclosporin, nephrotic syndrome, pharmacokinetics, children
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| remission | Nephrotic patients in remission | |
| relapse | Nephrotic patients in recidive |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startFeb 2007
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana dos Santos Henriques, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616446
- Sponsor's protocol ID
- CLINICS-D-12-00179R1
- Status last verified
- May 2012
- First submitted
- 7 Jun 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.6061/clinics/2012(10)12.
PubMed 23070347
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME
- ClinicalTrials.gov ID
- NCT01616446
- Acronym / sponsor ID
- CLINICS-D-12-00179R1
- Conditions
- Nephrotic Syndrome
- Keywords
- cyclosporin, nephrotic syndrome, pharmacokinetics, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remission | – | –Nephrotic patients in remission |
| relapse | – | –Nephrotic patients in recidive |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Iidiopathic nephrotic syndrome followed in the Pediatric Nephrology Unit of Instituto da Criança-HCFMUSP
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- renal and hepatic function abnormalities
- presence of infectious disease
- clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Derived from this study: PubMed 23070347Henriques 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. doi: 10.6061/clinics/2012(10)12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.