Anemia, Iron DeficiencyPhase 4NCT03286205
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
A Phase 4 study testing IV iron in people with Anemia, Iron Deficiency, run by Sutter Gould Medical Foundation at 1 site in United States.
Trial summary
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- IV iron
- 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
- 14 Apr 2015to 31 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years old.
- Being treated by a Sutter Health Physician.
- Hemoglobin of < 10mg/dl for Men and Women
- Ferritin </= 10ng/ml
- Patients in whom oral administration is unsatisfactory or impossible.
Who cannot join
- Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
- Anemia due to acute blood loss; menorrhagia is allowed.
- Patients with a current illness known to interact with iron status.
- Patients unwilling to consent to required blood draws.
- Patients who are viewed as unable to complete treatment, based on PI recommendation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sutter Gould Medical Foundation
Modesto, California, 95355
About this study
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.
Read the detailed description
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- IV iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ironDrug
IV iron infusion based on weekly or every 3 week dosage.
| Study group | Role | What they receive |
|---|---|---|
| Weekly Dosage | Active comparator | weekly dose of 100mg Receives: Drug: IV iron |
| 3 week dosage | Active comparator | every 3 week dosage. Receives: Drug: IV iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
superior dosing regimen exists for INfed
shown by a 2gm/dl increase in HgB
Measured: 3 years
High Dose Effect
INfed can be given at high dose without an increase in AE and/or SAEs frequency
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start14 Apr 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Why it stopped: IP unavailable at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sutter Gould Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Adkins, Sutter Gould Medical Foundation
- Investigators
- David Adkins, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286205
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2019
- First submitted
- 14 Sep 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
- ClinicalTrials.gov ID
- NCT03286205
- Acronym / sponsor ID
- 001
- Conditions
- Anemia, Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IP unavailable at site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sutter Gould Medical FoundationUniversity, hospital or other
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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 establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.
Detailed description
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Dosage | Active comparator | Drug: IV ironweekly dose of 100mg |
| 3 week dosage | Active comparator | Drug: IV ironevery 3 week dosage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over the age of 18 years old.
- Being treated by a Sutter Health Physician.
- Hemoglobin of < 10mg/dl for Men and Women
- Ferritin </= 10ng/ml
- Patients in whom oral administration is unsatisfactory or impossible.
Key exclusion criteria (5 listed)
- Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
- Anemia due to acute blood loss; menorrhagia is allowed.
- Patients with a current illness known to interact with iron status.
- Patients unwilling to consent to required blood draws.
- Patients who are viewed as unable to complete treatment, based on PI recommendation.
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 |
|---|---|---|
| IV ironIV iron infusion based on weekly or every 3 week dosage. | Drug | 3 week dosage, Weekly Dosage |
Primary outcome
superior dosing regimen exists for INfed
Time frame: 3 years
shown by a 2gm/dl increase in HgB
High Dose Effect
Time frame: 3 years
INfed can be given at high dose without an increase in AE and/or SAEs frequency
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 5 Jun 2019.
- 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.
David Adkins, MD principal investigator
Principal Investigator
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 IV iron in people with Anemia, Iron Deficiency, run by Sutter Gould Medical Foundation 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 5 inclusion and 5 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 5 Jun 2019. 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 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?
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?
superior dosing regimen exists for INfed (time frame: 3 years). The study lists 2 primary outcomes in all. 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 5 Jun 2019.