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

The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.

Study Overview

• Status: Withdrawn
• Conditions: Anemia, Iron Deficiency
• Intervention / Treatment: Drug: IV iron

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Modesto, California, United States, 95355
      • Sutter Gould Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weekly Dosage; weekly dose of 100mg	Drug: IV iron; IV iron infusion based on weekly or every 3 week dosage.
Active Comparator: 3 week dosage; every 3 week dosage.	Drug: IV iron; IV iron infusion based on weekly or every 3 week dosage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sutter Gould Medical Foundation
• Investigators: Principal Investigator: David Adkins, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2015
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No