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

This study is currently recruiting participants.

Verified April 2013 by Soroka University Medical Center

Sponsor:

Information provided by (Responsible Party):

David Tovbin, Soroka University Medical Center

ClinicalTrials.gov Identifier:

NCT00560976

First received: November 18, 2007

Last updated: April 17, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 18, 2007

Last Updated Date

April 17, 2013

Start Date ^ICMJE

December 2005

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels [ Time Frame: 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. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Serum NGAL levels [ Time Frame: Basal levels and changes induced by dialysis without and with intravenous (IV) iron administration ]

Change History

Complete list of historical versions of study NCT00560976 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Relation of serum NGAL levels and changes in this parameter to seum iron, transferrin saturation, ferritin, c-reactive protein and Il-6 levels [ Time Frame: Relation of serum NGAL levels to the above parameters at baseline and following dialysis without and with IV iron administration ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Failure Chronic Requiring Hemodialysis

Intervention ^ICMJE

Drug: Iron Saccharate (Venofer)

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).

Other Name: Ferric gluconate (Ferrlecit)

Study Arm (s)

Experimental: Iron Saccharate (Venofer)

IV Iron Saccharate (Venofer)100 mg

Intervention: Drug: Iron Saccharate (Venofer)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 88 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: David Tovbin, MD

972-54-296579

dtovbin@bgu.ac.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00560976

Other Study ID Numbers ^ICMJE

sor419105ctil

Has Data Monitoring Committee

Responsible Party

David Tovbin, Soroka University Medical Center

Study Sponsor ^ICMJE

Soroka University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Tovbin, MD

Soroka University Medical Center

Information Provided By

Soroka University Medical Center

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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