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

Sutter Gould Medical Foundation

Status and phase: Withdrawn; Phase 4

Conditions: Anemia, Iron Deficiency

Treatments: Drug: IV iron

Study type: Interventional

Funder types: Other

Identifiers

NCT03286205

001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Weekly Dosage

Active Comparator group

Description:

weekly dose of 100mg

Treatment:

Drug: IV iron

3 week dosage

Active Comparator group

Description:

every 3 week dosage.

Treatment:

Drug: IV iron