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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 Withdrawn at 1 site in United States.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Why this study was withdrawn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.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Anemia, Iron Deficiency
03

Who can participate

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

Inclusion criteria

  1. Patients over the age of 18 years old.
  2. Being treated by a Sutter Health Physician.
  3. Hemoglobin 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.
04

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

  • DrugIV iron

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

05

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

06

Study locations

1 site
  • Sutter Gould Medical Foundation
    Modesto, California 95355, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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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