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

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Iron Saccharate (Venofer)

About this trial

This is an interventional treatment trial for Renal Failure Chronic Requiring Hemodialysis focused on measuring neutrophil gelatinase associated lipocalin, hemodialysis, iron, inflammation, Oxidative Stress

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Nephrology, Soroka University Medical center
Bnai-zion Medical Center,Nephrology,
Department of Nephrology, Wolfson Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iron Saccharate (Venofer)

Arm Description

IV Iron Saccharate (Venofer)100 mg

Outcomes

Primary Outcome Measures

CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels

Secondary Outcome Measures

Full Information

NCT ID

NCT00560976

First Posted

November 18, 2007

Last Updated

April 17, 2013

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00560976

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2005 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure Chronic Requiring Hemodialysis

Keywords

neutrophil gelatinase associated lipocalin, hemodialysis, iron, inflammation, Oxidative Stress

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iron Saccharate (Venofer)

Arm Type

Experimental

Arm Description

IV Iron Saccharate (Venofer)100 mg

Intervention Type

Drug

Intervention Name(s)

Iron Saccharate (Venofer)

Other Intervention Name(s)

Ferric gluconate (Ferrlecit)

Intervention Description

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).

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Tovbin, MD

Phone

972-54-296579

dtovbin@bgu.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Tovbin, MD

Organizational Affiliation

Soroka University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nephrology, Soroka University Medical center

City

Beer-Sheva

ZIP/Postal Code

84101

Country

Israel

Individual Site Status

Completed

Facility Name

Bnai-zion Medical Center,Nephrology,

City

Haifa

Country

Israel

Individual Site Status

Completed

Facility Name

Department of Nephrology, Wolfson Medical Center

City

Holon

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Biro, MD

Phone

97235028285

abiro@wolfson.health.gov.il

First Name & Middle Initial & Last Name & Degree

Katzir Zeev, MD

Phone

97235028291

Katzir@wolfson.health.gov.il

First Name & Middle Initial & Last Name & Degree

Alexander Biro, MD

12. IPD Sharing Statement

Learn more about this trial

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

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