Hemodialysis PatientsNCT00638300
Removal of Ligand-bound Iron During Intravenous (IV) Iron Administration in Hemodialysis (HD)
A study testing large pore (FX80) compared to small pore dialyzer (F8HPS), Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L and Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L in people with Hemodialysis Patients, run by Soroka University Medical Center at 3 sites in Israel.
Trial summary
The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- large pore (FX80) compared to small pore dialyzer (F8HPS), Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L and Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesIsrael
- Study dates
- Mar 2008to Jul 2010
- 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 3 weeks prior to the study
- Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
HD unit in Department of Nephrology in Soroka Universty Medical Center
Beersheba, 84101
HD unit in Bnai-zion Medical Center
Haifa
Rivka Ziv Medical center
Safed
About this study
Official title: Removal of Ligand-bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers
The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
Read the detailed description
Most hemodialysis(HD) patients receive during HD intravenous iron compounds, which are composed of an iron core and a sugar polymer shell.
A small percentage of iron from the iron compound is released to the plasma, and may be associated with increased oxidative stress and protein oxidation. The study's hypothesis is that HD with large pore dialyzers may remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
Ligand-bound iron removal is also hypothesized to be affected by dialysate calcium and bicarbonate concentrations, which may affect iron-ligand binding.
Study Specific aims are:
To evaluate
- Iron removal assessing dialysate iron levels.
- Effect of iron removal and it's associated experimental conditions on patient status, assessing plasma AOPP levels and inflammation related parameters
Study include 3 parts
- Comparing large to small pore dialyzers (To achieve baseline uniform conditions, patients will be on uniform dialysate bicarbonate and calcium concentrations of 33 mEq/L and 3 mEq/L,respectively, using large pore dialyzers during this part, besides the 2 HD sessions evaluating low pore dialyzers) and after few week break Using large pore dialyzers to compare
- Low to high dialysate bicarbonate concentration (using uniform dialysate calcium concentrations of 3 mEq/L) and after few week break
- Low to high dialysate calcium concentrations concentration (using uniform dialysate bicarbonate of 33 mEq/L)
In each part, patients will be first evaluated in HD without IV iron administration, which will serve as a control for evaluation after a week in HD with IV iron administration.
In each part, patients will be randomized to start either with one of the 2 experimental conditions, and after 1 week without evaluation will cross-over to the other experimental condition.
Patients may participate in 1,2 or the 3 parts of study depending on their will and condition.
- Conditions
- Hemodialysis Patients
- Being tested
- large pore (FX80) compared to small pore dialyzer (F8HPS), Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L, Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
- Keywords
- hemodialysis, iron, inflammation, atomic absorption, dialysate, advanced oxidation protein products, large pore dialysate, bicarbonate, calcium, citrate, ligand
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
large pore (FX80) compared to small pore dialyzer (F8HPS)Device
Effect of pore size
Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/LOther
Effect of dialysate bicarbonate concentration
Dialysate calcium of 3 mEq/L compared to 2.5 mEq/LOther
Effect of dialysate calcium concentration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | large pore dialyzers (FX80, Fresenius, Germany) Receives: Device: large pore (FX80) compared to small pore dialyzer (F8HPS) |
| 2 | Experimental | small pore dialyzers ( F8HPS, Fresenius, Germany) Receives: Device: large pore (FX80) compared to small pore dialyzer (F8HPS) |
| A | Experimental | dialysate bicarbonate concentration of 33 mEq/l Receives: Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L |
| B | Experimental | dialysate bicarbonate concentration of 40 mEq/l Receives: Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L |
| I | Experimental | dialysate calcium concentration of 3 mEq/L Receives: Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L |
| II | Experimental | dialysate calcium concentration of 2.5 mEq/L Receives: Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP)
Measured: Before HD, after 1 hour of HD with or without IV iron and at end of HD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bnai Zion Medical Center, Rivka Ziv Medical Center
- Investigators
- David Tovbin, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638300
- Sponsor's protocol ID
- sor421306ctil
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Ligand-bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers
- ClinicalTrials.gov ID
- NCT00638300
- Acronym / sponsor ID
- sor421306ctil
- Conditions
- Hemodialysis Patients
- Keywords
- hemodialysis, iron, inflammation, atomic absorption, dialysate, advanced oxidation protein products, large pore dialysate, bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Bnai Zion Medical Center, Rivka Ziv Medical Center
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Mar 2008 (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 study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
Detailed description
Most hemodialysis(HD) patients receive during HD intravenous iron compounds, which are composed of an iron core and a sugar polymer shell.
A small percentage of iron from the iron compound is released to the plasma, and may be associated with increased oxidative stress and protein oxidation. The study's hypothesis is that HD with large pore dialyzers may remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
Ligand-bound iron removal is also hypothesized to be affected by dialysate calcium and bicarbonate concentrations, which may affect iron-ligand binding.
Study Specific aims are:
To evaluate
- Iron removal assessing dialysate iron levels.
- Effect of iron removal and it's associated experimental conditions on patient status, assessing plasma AOPP levels and inflammation related parameters
Study include 3 parts
- Comparing large to small pore dialyzers (To achieve baseline uniform conditions, patients will be on uniform dialysate bicarbonate and calcium concentrations of 33 mEq/L and 3 mEq/L,respectively, using large pore dialyzers during this part, besides the 2 HD sessions evaluating low pore dialyzers) and after few week break Using large pore dialyzers to compare
- Low to high dialysate bicarbonate concentration (using uniform dialysate calcium concentrations of 3 mEq/L) and after few week break
- Low to high dialysate calcium concentrations concentration (using uniform dialysate bicarbonate of 33 mEq/L)
In each part, patients will be first evaluated in HD without IV iron administration, which will serve as a control for evaluation after a week in HD with IV iron administration.
In each part, patients will be randomized to start either with one of the 2 experimental conditions, and after 1 week without evaluation will cross-over to the other experimental condition.
Patients may participate in 1,2 or the 3 parts of study depending on their will and condition.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: large pore (FX80) compared to small pore dialyzer (F8HPS)large pore dialyzers (FX80, Fresenius, Germany) |
| 2 | Experimental | Device: large pore (FX80) compared to small pore dialyzer (F8HPS)small pore dialyzers ( F8HPS, Fresenius, Germany) |
| A | Experimental | Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/Ldialysate bicarbonate concentration of 33 mEq/l |
| B | Experimental | Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/Ldialysate bicarbonate concentration of 40 mEq/l |
| I | Experimental | Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/Ldialysate calcium concentration of 3 mEq/L |
| II | Experimental | Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/Ldialysate calcium concentration of 2.5 mEq/L |
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 3 weeks prior to the study
- Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation
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 |
|---|---|---|
| large pore (FX80) compared to small pore dialyzer (F8HPS)Effect of pore size | Device | 1, 2 |
| Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/LEffect of dialysate bicarbonate concentration | Other | A, B |
| Dialysate calcium of 3 mEq/L compared to 2.5 mEq/LEffect of dialysate calcium concentration | Other | I, II |
Primary outcome
1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP)
Time frame: Before HD, after 1 hour of HD with or without IV iron and at end of HD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
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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 large pore (FX80) compared to small pore dialyzer (F8HPS), Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L and Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L in people with Hemodialysis Patients, 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: finished, as of the sponsor's last update on 13 Jul 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP) (time frame: Before HD, after 1 hour of HD with or without IV iron and at end of HD). 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 13 Jul 2010; AzTrials last refreshed its copy on 7 Nov 2026.