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:
Soroka University Medical Center
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
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Purpose
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
| Condition | Intervention |
|---|---|
|
Renal Failure Chronic Requiring Hemodialysis |
Drug: Iron Saccharate (Venofer) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration |
Resource links provided by NLM:
Drug Information available for:
Sodium gluconate
Manganese gluconate
Sodium ferric gluconate complex
U.S. FDA Resources
Further study details as provided by Soroka University Medical Center:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Iron Saccharate (Venofer)
IV Iron Saccharate (Venofer)100 mg
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 88 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560976
Contacts
| Contact: David Tovbin, MD | 972-54-296579 | dtovbin@bgu.ac.il |
Locations
| Israel | |
| Department of Nephrology, Soroka University Medical center | Completed |
| Beer-Sheva, Israel, 84101 | |
| Bnai-zion Medical Center,Nephrology, | Completed |
| Haifa, Israel | |
| Department of Nephrology, Wolfson Medical Center | Recruiting |
| Holon, Israel | |
| Contact: Alexander Biro, MD 97235028285 abiro@wolfson.health.gov.il | |
| Contact: Katzir Zeev, MD 97235028291 Katzir@wolfson.health.gov.il | |
| Principal Investigator: Alexander Biro, MD | |
Sponsors and Collaborators
Soroka University Medical Center
Investigators
| Principal Investigator: | David Tovbin, MD | Soroka University Medical Center |
More Information
No publications provided
| Responsible Party: | David Tovbin, Dr David Tovbin, Department of Nephrology, Soroka University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00560976 History of Changes |
| Other Study ID Numbers: | sor419105ctil |
| Study First Received: | November 18, 2007 |
| Last Updated: | April 17, 2013 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Soroka University Medical Center:
|
neutrophil gelatinase associated lipocalin hemodialysis iron inflammation Oxidative Stress |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Ferric gluconate Ferric oxide, saccharated Ferric Compounds Iron |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013