Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT05110768
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy
Sponsor:
Rockwell Medical Technologies, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: