Iron DeficiencyPhase 2NCT02977611
The Safety of a High-Dose, Rapid Infusion of Iron Sucrose
A Phase 2 study testing Iron sucrose in people with Iron Deficiency, run by The Guthrie Clinic at 1 site in United States.
Trial summary
Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Iron sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to May 2017
- Phase
- Phase 2
- 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
- Any patient requiring iron infusion
Who cannot join
- Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population
Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic.
The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.
- Conditions
- Iron Deficiency
- Being tested
- Iron sucrose
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sucroseDrug
Also called Venofer
Iron sucrose will be infused at dose of 500 mg over a one hour period
| Study group | Role | What they receive |
|---|---|---|
| High Dose, Rapid Infusion Iron Sucrose | Experimental | Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours. Receives: Drug: Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events in the study population attributed to drug administration.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: FDA Clinical Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Lash, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977611
- Sponsor's protocol ID
- 1611-56
- Status last verified
- Oct 2017
- First submitted
- 28 Nov 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population
- ClinicalTrials.gov ID
- NCT02977611
- Acronym / sponsor ID
- 1611-56
- Conditions
- Iron Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA Clinical Hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Nov 2016 (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.
Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic.
The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Dose, Rapid Infusion Iron Sucrose | Experimental | Drug: Iron sucrosePatients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient requiring iron infusion
Key exclusion criteria (1 listed)
- Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.
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 sucroseAlso: VenoferIron sucrose will be infused at dose of 500 mg over a one hour period | Drug | High Dose, Rapid Infusion Iron Sucrose |
Primary outcome
incidence of adverse events in the study population attributed to drug administration.
Time frame: 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Bradley Lash, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron sucrose in people with Iron Deficiency, run by The Guthrie Clinic at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 18 Oct 2017. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 adverse events in the study population attributed to drug administration. (time frame: 4 hours). 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 Oct 2017.