The main purpose is to determine whether FPC, administered via infusion, is safe and effective for the treatment of iron deficiency anemia (IDA) in patients receiving Home Infusion therapies (HI).
This is a prospective, randomized, placebo-controlled, multi-center, clinical trial of the safety and efficacy of FPC infusion for patients diagnosed with IDA receiving therapy home infusion therapy. The study will be open label placebo-controlled using an objective endpoint (Hgb). A total of 75 home infusion patients will be enrolled. Subjects will be randomized to receive FPC starting at Day 1; Patients in the FPC arm will receive FPC 20 mg Fe IV by infusion over 12 hours every other day (qOD), for a total duration of up to 12 weeks plus a one-week follow-up after the last study drug treatment. For patients whose duration of therapy is \>10 hours, patients will receive a 12-hour infusion of FPC. Patients in the placebo arms will receive IV placebo on the same schedule for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Triferic AVNU is an iron salt that is approved for the maintenance of Hgb in chronic kidney disease patients on hemodialysis. It is experimental in this study because it has not yet been approved for patients receiving home infusion therapy
normal TPN solution without FPC on alternate days with TPN supplemented with multivitamins.
The efficacy of FPC in treating Iron deficiency anemia (IDA) by FPC infusion in patients receiving Home Infusion therapies (HI).
The efficacy will be done by assessing the change from baseline in serum iron to end of treatment (EoT). EoT is defined as the average of the last 2 bi-weekly Hgb values obtained at end of study or if the patient is prematurely terminated for any reason.
Time frame: Change from Baseline in serum iron at 17 weeks
The proportion of "patient responders,"
≥ 1 g/dL increase from baseline in Hgb.
Time frame: Change from Baseline in HgB at 17 weeks.
Iron delivery to the erythron.
estimated by change in serum reticulocyte count, reticulocyte hemoglobin (CHr) and soluble transferrin receptor (sTfR) levels.
Time frame: Change from Baseline in CHr and sTfR levels at 17 weeks
Need for rescue therapy
The number of patients requiring oral iron, intravenous iron and/or blood /packed RBC transfusions and the amount of intravenous iron and blood/packed cell transfusions.
Time frame: up to 17 weeks
Treatment (Patient) failure.
Incidence and time to development of iron deficiency defined as serum ferritin \< 100 µg/L and TSAT\< 20% confirmed by a consecutive repeat value (any time ≥ 1 day and ≤ 2 weeks after the first value).
Time frame: up to 17 weeks
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