NCT05110768

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

A Randomized, Placebo-controlled Study of the Treatment of Iron Deficiency Anemia (IDA) by Ferric Pyrophosphate Citrate (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Triferic AVNU	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
OTHER	Placebo	normal TPN solution without FPC on alternate days with TPN supplemented with multivitamins.

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-04-30
• Completion: 2022-05-30
• First posted: 2021-11-08
• Last updated: 2021-11-08

Regulatory

• FDA-regulated drug study