NCT03286205

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

3.4 years

First QC Date

September 14, 2017

Last Update Submit

June 3, 2019

Conditions

Anemia, Iron Deficiency

Outcome Measures

Primary Outcomes (2)

  • superior dosing regimen exists for INfed

    shown by a 2gm/dl increase in HgB

    3 years

  • High Dose Effect

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

    3 years

Study Arms (2)

Weekly Dosage

ACTIVE COMPARATOR

weekly dose of 100mg

Drug: IV iron

3 week dosage

ACTIVE COMPARATOR

every 3 week dosage.

Drug: IV iron

Interventions

IV ironDRUG

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

3 week dosageWeekly Dosage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutter Gould Medical Foundation

Modesto, California, 95355, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferryl iron

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David Adkins, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

April 14, 2015

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)