NCT01616446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
Last Updated

June 11, 2012

Status Verified

May 1, 2012

Enrollment Period

2.5 years

First QC Date

June 7, 2012

Last Update Submit

June 8, 2012

Conditions

Nephrotic Syndrome

Keywords

cyclosporinnephrotic syndromepharmacokineticschildren

Study Arms (2)

remission

Nephrotic patients in remission

relapse

Nephrotic patients in recidive

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • renal and hepatic function abnormalities
  • presence of infectious disease
  • clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23070347DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

February 1, 2007

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

June 11, 2012

Record last verified: 2012-05

Locations

BR(1)