A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
- Registration Number
- NCT03286205
- Lead Sponsor
- Sutter Gould Medical Foundation
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 week dosage IV iron every 3 week dosage. Weekly Dosage IV iron weekly dose of 100mg
- Primary Outcome Measures
Name Time Method superior dosing regimen exists for INfed 3 years shown by a 2gm/dl increase in HgB
High Dose Effect 3 years INfed can be given at high dose without an increase in AE and/or SAEs frequency
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sutter Gould Medical Foundation
🇺🇸Modesto, California, United States