Renal Failure Chronic Requiring HemodialysisNCT00560976
Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration
A study testing Iron Saccharate (Venofer) in people with Renal Failure Chronic Requiring Hemodialysis, run by Soroka University Medical Center at 3 sites in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- Iron Saccharate (Venofer)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesIsrael
- Study dates
- Dec 2005to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hemodialysis patients
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 1 recruiting
- Completed
Department of Nephrology, Soroka University Medical center
Beersheba, 84101
- Completed
Bnai-zion Medical Center,Nephrology,
Haifa
- Recruiting
Department of Nephrology, Wolfson Medical Center
Holon
Alexander Biro, MD, 97235028285, abiro@wolfson.health.gov.il
Katzir Zeev, MD, 97235028291, Katzir@wolfson.health.gov.il
About this study
Official title: Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration
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
Read the 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.
- Being tested
- Iron Saccharate (Venofer)
- Keywords
- neutrophil gelatinase associated lipocalin, hemodialysis, iron, inflammation, Oxidative Stress
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Saccharate (Venofer)Drug
Also called Ferric gluconate (Ferrlecit)
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).
| Study group | Role | What they receive |
|---|---|---|
| Iron Saccharate (Venofer) | Experimental | IV Iron Saccharate (Venofer)100 mg Receives: Drug: Iron Saccharate (Venofer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startDec 2005
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Tovbin, Soroka University Medical Center
- Investigators
- David Tovbin, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560976
- Sponsor's protocol ID
- sor419105ctil
- Status last verified
- Apr 2013
- First submitted
- 18 Nov 2007
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration
- ClinicalTrials.gov ID
- NCT00560976
- Acronym / sponsor ID
- sor419105ctil
- Keywords
- neutrophil gelatinase associated lipocalin, hemodialysis, iron, inflammation, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Saccharate (Venofer) | Experimental | Drug: Iron Saccharate (Venofer)IV Iron Saccharate (Venofer)100 mg |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hemodialysis patients
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Saccharate (Venofer)Also: Ferric gluconate (Ferrlecit)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). | Drug | Iron Saccharate (Venofer) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tovbin, MD principal investigator
Soroka University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Saccharate (Venofer) in people with Renal Failure Chronic Requiring Hemodialysis, run by Soroka University Medical Center at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Tovbin, MD (972-54-296579, dtovbin@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013.