Iron Deficiency AnemiaPhase 4NCT00593619
Trial Comparing the Safety of Two Different Intravenous Iron Formulations
A Phase 4 study testing Iron dextran and Iron sucrose in people with Iron Deficiency Anemia and Perioperative Blood Conservation, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, Perioperative Blood Conservation
- What is being tested?
- Iron dextran and Iron sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 100
- To be receiving intravenous iron
Who cannot join
- Age < 18
- Hemodialysis
- Previous exposure to intravenous iron
- Unable to provide written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.
- Being tested
- Iron dextran, Iron sucrose
- Keywords
- Intravenous Iron, Safety, Perioperative, Iron deficiency, Non hemodialysis population, Perioperative blood conservation
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron dextranDrug
Also called Infufer, Sandoz Canada Incorporated, DIN 02221780
300mg in 250cc normal saline given over 2 hours
Iron sucroseDrug
Also called Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716
300mg in 250cc normal saline given over 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Iron Dextran | Active comparator | Not described Receives: Drug: Iron dextran |
| Iron Sucrose | Active comparator | Not described Receives: Drug: Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe adverse drug reactions (ADRs)
Measured: Immediate - during infusion
Secondary outcomes (8)
Incidence of serious adverse drug reactions (ADRs)
Measured: Immediate and delayed - within 24hrs post infusion
Incidence of anaphylactic/anaphylactoid ADRs
Measured: Immediate - during infusion
Incidence of combined mild and moderate ADRs
Measured: Immediate - during infusion
Incidence of delayed ADRs
Measured: delayed - within 24hrs post infusion
Incidence of all-cause mortality
Measured: Immediate and delayed - within 24hrs post infusion
Physician and nursing time required to manage ADRs
Measured: Immediate and delayed - within 24hrs post infusion
Response in laboratory parameters
Measured: Within 1 month
Cost effectiveness
Measured: Completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Interim Analysis and review by Data Safety Monitoring Board
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Ian H Chin-Yee, MD, FRCPC, Principal investigator, London Health Sciences CentreFiona E Ralley, MB ChB, FRCA, Principal investigator, London Health Sciences CentreCyrus C Hsia, MD,FRCPC, Study director, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593619
- Sponsor's protocol ID
- HSREB13767
- Status last verified
- Feb 2009
- First submitted
- 3 Jan 2008
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
- ClinicalTrials.gov ID
- NCT00593619
- Acronym / sponsor ID
- HSREB13767
- Keywords
- Intravenous Iron, Safety, Perioperative, Iron deficiency, Non hemodialysis population, Perioperative blood conservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Interim Analysis and review by Data Safety Monitoring Board
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 15 Jan 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 purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Dextran | Active comparator | Drug: Iron dextran |
| Iron Sucrose | Active comparator | Drug: Iron sucrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 100
- To be receiving intravenous iron
Key exclusion criteria (4 listed)
- Age < 18
- Hemodialysis
- Previous exposure to intravenous iron
- Unable to provide written consent
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 dextranAlso: Infufer, Sandoz Canada Incorporated, DIN 02221780300mg in 250cc normal saline given over 2 hours | Drug | Iron Dextran |
| Iron sucroseAlso: Venofer, Luitpold Pharmaceuticals Inc., DIN 02243716300mg in 250cc normal saline given over 2 hours | Drug | Iron Sucrose |
Primary outcome
Incidence of severe adverse drug reactions (ADRs)
Time frame: Immediate - during infusion
8 secondary outcomes
Incidence of serious adverse drug reactions (ADRs)
Time frame: Immediate and delayed - within 24hrs post infusion
Incidence of anaphylactic/anaphylactoid ADRs
Time frame: Immediate - during infusion
Incidence of combined mild and moderate ADRs
Time frame: Immediate - during infusion
Incidence of delayed ADRs
Time frame: delayed - within 24hrs post infusion
Incidence of all-cause mortality
Time frame: Immediate and delayed - within 24hrs post infusion
Physician and nursing time required to manage ADRs
Time frame: Immediate and delayed - within 24hrs post infusion
Response in laboratory parameters
Time frame: Within 1 month
Cost effectiveness
Time frame: Completion of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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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.
Ian H Chin-Yee, MD, FRCPC principal investigator
London Health Sciences Centre
Fiona E Ralley, MB ChB, FRCA principal investigator
London Health Sciences Centre
Cyrus C Hsia, MD,FRCPC study director
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron dextran and Iron sucrose in people with Iron Deficiency Anemia and Perioperative Blood Conservation, run by London Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 4 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: paused, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Incidence of severe adverse drug reactions (ADRs) (time frame: Immediate - during infusion). 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 3 Mar 2009.