Iron Deficiency AnemiaPhase 2NCT05110768
Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy
A Phase 2 study testing Triferic AVNU in people with Iron Deficiency Anemia, run by Rockwell Medical Technologies, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Triferic AVNU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 30 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.)
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- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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
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).
Read the 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
- Being tested
- Triferic AVNU, Placebo
- Keywords
- Ferric Pyrophosphate Citrate
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triferic AVNUDrug
Also called Ferric Pyrophosphate Citrate (FPC)
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
PlaceboOther
normal TPN solution without FPC on alternate days with TPN supplemented with multivitamins.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in serum iron at 17 weeks
Secondary outcomes (4)
The proportion of "patient responders,"
≥ 1 g/dL increase from baseline in Hgb.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start30 Nov 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockwell Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond D Pratt, MD, FACP, Study director, Rockwell Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110768
- Sponsor's protocol ID
- RMFPC-HI-01
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05110768
- Acronym / sponsor ID
- RMFPC-HI-01
- Conditions
- Iron Deficiency Anemia
- Keywords
- Ferric Pyrophosphate Citrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FPC 20 mg Fe IV by infusion over 12 hours every other day | Experimental | Drug: Triferic AVNUPatients 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. |
| Placebo | Placebo comparator | Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triferic AVNUAlso: Ferric Pyrophosphate Citrate (FPC)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 | Drug | FPC 20 mg Fe IV by infusion over 12 hours every other day |
| Placebonormal TPN solution without FPC on alternate days with TPN supplemented with multivitamins. | Other | Placebo |
Primary outcome
The efficacy of FPC in treating Iron deficiency anemia (IDA) by FPC infusion in patients receiving Home Infusion therapies (HI).
Time frame: Change from Baseline in serum iron at 17 weeks
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.
4 secondary outcomes
The proportion of "patient responders,"
Time frame: Change from Baseline in HgB at 17 weeks.
Iron delivery to the erythron.
Time frame: Change from Baseline in CHr and sTfR levels at 17 weeks
Need for rescue therapy
Time frame: up to 17 weeks
Treatment (Patient) failure.
Time frame: up to 17 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond D Pratt, MD, FACP study director
Rockwell Medical
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triferic AVNU in people with Iron Deficiency Anemia, run by Rockwell Medical Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Hoffman (2489609009, mhoffman@rockwellmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of FPC in treating Iron deficiency anemia (IDA) by FPC infusion in patients receiving Home Infusion therapies (HI). (time frame: Change from Baseline in serum iron at 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.