Renal Function Measurements in Children | NCT01092260

Studies
Renal Function Measurements in Children

NCT01092260

Sponsor

Haukeland University Hospital

Status

Completed

Last Update Posted

Jan 5, 2012Estimated

Enrollment

96Actual

Phase

Not provided

Conditions

Renal Function Disorder

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 23, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2012

Last Update Posted Date

Jan 5, 2012Estimated

Name	Class
Oslo University Hospital	OTHER

Description Module

Brief Summary

The purpose of this study is to validate a feasible, safe and reliable iohexol plasma clearance method in routine monitoring of the renal function (GFR) in children.

Different parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

96Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age < 18 years
Clinical indication for measurement of glomerular filtration rate

Exclusion Criteria:

Previous serious reaction on Iohexol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children with clinical indication for measurement of renal function

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camilla Tondel, MD	Haukeland University Hospital, Bergen, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen		5021	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37517327	Derived	Salvador CL, Flemmen PTK, Tondel C, Bliksrud YT, Tsui EFF, Brun A, Bjerre A, Morkrid L. Renal function, sex and age influence purines and pyrimidines in urine and could lead to diagnostic misinterpretation. Mol Genet Metab. 2023 Nov;140(3):107649. doi: 10.1016/j.ymgme.2023.107649. Epub 2023 Jul 5.
34853376	Derived

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases