Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy

• Status: Not yet recruiting
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockwell Medical Technologies, Inc.

Criteria

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Receiving a home infusion therapy requiring IV administration of fluid via an indwelling access device for up to 12 hours daily, 7 days a week, for >4 weeks

• Diagnosed with Iron deficiency anemia (Hgb <11.5 g/dL Female and <12 g/dL Male)

• CHr <29 pg./mL

• Serum Ferritin <100 ng/mL

• TSAT <20%

• Ability and willingness to adhere to the home infusion administration of FPC/Placebo.

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

• Use of oral or intravenous iron within 4 weeks prior to randomization.

• Pregnancy or lactation

• Any febrile illness (oral temperature > 100.4°F, 38°C) during screening.

• Treatment with another investigational drug within 30 days of Randomization

• Current smoker or tobacco use within ≥3 months

• Known cause of anemia other than iron deficiency (e.g., sickle cell disease, thalassemia, pure red cell aplasia, hemolytic anemia, myelodysplastic syndrome, Vitamin B12 deficiency …etc.)

• Vitamin deficiency at Screening Visit

• Iron overload that contraindicates further iron supplementation as deemed by the PI.

• Prior documented hypersensitivity reaction (anaphylaxis) to IV iron administration

• History of drug or alcohol abuse within the last 6 months.

• Known active tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study.

• Known positive status for hepatitis B surface antigen (hepatitis B testing is not required as part of this protocol).

• Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this protocol).

• Cirrhosis of the liver based on histological criteria or clinical criteria (e.g., presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy).

• Hepatitis C infection if ALT and/or AST levels are consistently greater than twice the upper limit of normal at any time during the 2 months prior to randomization.

• Subjects who are anticipated to be unable to complete the entire study (e.g., due to a concurrent disease).