Serum NGAL Levels in Hemodialysis (HD) Patients; Relation... | NCT00560976

Studies
Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration

NCT00560976

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

Apr 18, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Renal Failure Chronic Requiring Hemodialysis

Interventions

Iron Saccharate (Venofer)

Countries

Israel

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Nov 18, 2007

First Submission Date that Met QC Criteria

Nov 19, 2007

First Posted Date

Nov 20, 2007Estimated

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

Apr 17, 2013

Last Update Posted Date

Apr 18, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Tovbin, Dr David Tovbin, Department of Nephrology, Soroka University Medical CenterPrincipal Investigator

Lead Sponsor

Soroka University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess changes in serum levels of the siderophore binding protein NGAL by hemodialysis without and with intravenous iron administration

Detailed Description

Serum and urine levels of the siderophore binding protein neutrophil gelatinase associated lipocalin (NGAL) are increased in a number of renal diseases, but has not been evaluated yet in dialysis patients. Since NGAL is suggested to be related to inflammatory processes and iron homeostasis, which are a major problem in dialysis patients, this study aims to assess the relation of serum NGAL levels in hemodialysis (HD) patients to iron status, inflammation, hemodialysis and intravenous(IV) iron administration. Our hypothesis is that serum NGAL levels in HD patients are related to iron status and inflammation and may change following hemodialysis and/or acute or chronic IV iron administration.

The Specific aims are:

To assess the relations between basal serum NGAL levels to iron, dialysis, and inflammation related parameters.
To assess the effect of HD on serum NGAL levels and their relation with with iron, dialysis and inflammation related parameters.
To assess the effects of weekly 100 mg IV iron in the first hour of HD on serum NGAL levels, and the relation of pre IV iron serum NGAL levels with iron, oxidative stress and inflammation related parameters. These assessments will be performed in the first weekly HD.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iron Saccharate (Venofer)	Experimental	IV Iron Saccharate (Venofer)100 mg	Drug: Iron Saccharate (Venofer)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron Saccharate (Venofer)	Drug	Hemodialysis with IV iron administration of 100 mg Iron Saccharate (Venofer) in 150 ml 0.9 % saline to the arterial dialysis line during first hour of mid-week dialysis session. An alternative IV iron brand in some centers participating in the study could bebe 62.5 mg ferric gluconate (Ferrlecit).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels		To assess the effects of 100 mg IV iron in the first hour of the first weekly HD on the relation of pre IV iron serum NGAL levels with oxidative stress and inflammation related parameters.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic hemodialysis patients

Exclusion Criteria:

Acute disease (infection, thrombosis, ischemia, bleeding)
Hepatitis B, Hepatitis C or HIV
Intravenous iron administration or packed red cell transfusion in the last 4 weeks prior to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Tovbin, MD	Contact	972-54-296579		dtovbin@bgu.ac.il

Overall Officials

Name	Affiliation	Role
David Tovbin, MD	Soroka University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology, Soroka University Medical center	Completed	Beersheba		84101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077605	Ferric Oxide, Saccharated
C035552	ferric gluconate

Ancestor Terms

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005937	Glucaric Acid

Browse Leaves

Not provided

Browse Branches

Not provided