ClinicalTrials.gg
WithdrawnNCT03286205Updated Jun 5, 2019

A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.

A Phase 4 interventional study of IV iron in Anemia, Iron Deficiency, sponsored by Sutter Gould Medical Foundation. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-05.

Sponsored by Sutter Gould Medical Foundation · Phase 4, Interventional, and Treatment

Why this study was withdrawn
IP unavailable at site.

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Apr 2015, registered Sep 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies testing iron in Anemia, Iron-Deficiency — 3 open to participants now, 3 under way, none of them phase 3. Iron · Anemia, Iron-Deficiency.

Enrollment
23rd of 24
0 · median 107
Started
2015
the only one that year
Phase 4
11 of 24
2 open now
Registered
11th of 24
by date

Among the 24 studies testing iron in Anemia, Iron-Deficiency, this one is the 23rd largest by enrollment, is the only one that started in 2015, is one of 11 in phase 4, and was the 11th registered.

By phase

24 studies; the count open now beside each. This study's row is marked.

Phase 4this study11 · 2 open
No phase8 · 1 open
Phase 34 · 0 open
Phase 21 · 0 open

By the year they started

First in 1997; this study’s year is marked. 1 started in 2015.

Size and results

Median enrollment 107 across the 24 interventional studies. Of the 12 that completed or were terminated, 1 (8%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 24 studies testing iron in Anemia, Iron-Deficiency, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Anemia, Iron Deficiency
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients over the age of 18 years old.
  2. Being treated by a Sutter Health Physician.
  3. of \< 10mg/dl for Men and Women
  4. Ferritin \</= 10ng/ml
  5. Patients in whom oral administration is unsatisfactory or impossible.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
  2. Anemia due to acute blood loss; menorrhagia is allowed.
  3. Patients with a current illness known to interact with iron status.
  4. Patients unwilling to consent to required blood draws.
  5. Patients who are viewed as unable to complete treatment, based on PI recommendation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Weekly Dosage

    weekly dose of 100mg

    Drug: IV iron

  • Active comparator
    3 week dosage

    every 3 week dosage.

    Drug: IV iron

Interventions

  • IV iron infusion based on weekly or every 3 week dosage.

06

What researchers measure

Primary outcomes

  1. superior dosing regimen exists for INfed

    shown by a 2gm/dl increase in HgB

    Time frame: 3 years

  2. High Dose Effect

    INfed can be given at high dose without an increase in AE and/or SAEs frequency

    Time frame: 3 years

07

Study locations

1 site
  • Sutter Gould Medical Foundation
    Modesto, California 95355, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Aug 2018, 40 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2017
First posted
Sep 18, 2017
StartActual
Apr 14, 2015
Primary completionActual
Aug 31, 2018
CompletionActual
Aug 31, 2018
Last update
Jun 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03286205
Lead sponsor
Sutter Gould Medical Foundation
Responsible party
David Adkins (Principal Investigator, Sutter Gould Medical Foundation) — Principal investigator
First posted
Sep 18, 2017
Start date
Apr 14, 2015
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Jun 5, 2019

Study contacts

David Adkins, MD
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Iron

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