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

NCT05110768 | Unknown Phase 2 FDA Drug

• 1 other identifier: RMFPC-HI-01
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Iron Deficiency Anemia

Keywords

Ferric Pyrophosphate Citrate

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline in serum iron at 17 weeks

Secondary Outcomes (4)

• The proportion of "patient responders,"

  Change from Baseline in HgB at 17 weeks.

• Iron delivery to the erythron.

  Change from Baseline in CHr and sTfR levels at 17 weeks

• Need for rescue therapy

  up to 17 weeks

• Treatment (Patient) failure.

  up to 17 weeks

Study Arms (2)

FPC 20 mg Fe IV by infusion over 12 hours every other day

EXPERIMENTAL

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.

Drug: Triferic AVNU

Placebo

PLACEBO COMPARATOR

Patients in the placebo arms will receive IV placebo on the same schedule for 12 weeks. All patients are eligible to receive Rescue conventional IV iron if criteria are met and the patient's principal physician agrees.

Other: Placebo

Interventions

Triferic AVNU DRUG

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

Also known as: Ferric Pyrophosphate Citrate (FPC)

FPC 20 mg Fe IV by infusion over 12 hours every other day

Placebo OTHER

normal TPN solution without FPC on alternate days with TPN supplemented with multivitamins.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raymond D Pratt, MD, FACP

  Rockwell Medical

  STUDY DIRECTOR

Central Study Contacts

Marc Hoffman

CONTACT

2489609009; mhoffman@rockwellmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 8, 2021
• Study Start: November 30, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share