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

Anemia, Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03286205
• Other study ID #: 001
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 14, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: June 2019
• Source: Sutter Gould Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Sutter Gould Medical Foundation	Modesto	California

Sponsors (1)

Lead Sponsor	Collaborator
Sutter Gould Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	superior dosing regimen exists for INfed	shown by a 2gm/dl increase in HgB	3 years
Primary	High Dose Effect	INfed can be given at high dose without an increase in AE and/or SAEs frequency	3 years