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

Sutter Gould Medical Foundation

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Anemia, Iron Deficiency

Interventions

IV ironDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sutter Gould Medical Foundation

Modesto, California, United States

Outcomes

Primary Outcomes

superior dosing regimen exists for INfed

shown by a 2gm/dl increase in HgB

Time frame: 3 years

High Dose Effect

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

Time frame: 3 years

Data from ClinicalTrials.gov

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