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Heart Failure, Left SidedPhase 4ORION-LVAD-1NCT03774615

ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices

A Phase 4 study testing Ferric maltol 30 mg (Feraccru®) in people with Heart Failure, Left Sided and Anemia, Iron Deficiency, run by Hannover Medical School at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ferric maltol 30 mg (Feraccru®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteGermany
Study dates
18 Mar 2019to 29 Nov 2019
Phase
Phase 4
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

  • Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
  • Male and female patients ≥18 years at day of inclusion
  • Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
  • Patients that have an LVAD implanted for chronic heart failure and which are clinically stable for at least 6 months after LVAD implantation in the opinion of the investigator
  • 6 min walk distance >50 m
  • Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and <12 g/dl in females or ≥8 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-300 µg/l and transferrin saturation <20% at screening
  • Women of childbearing potential must:
  • Have a negative pregnancy test at screening Agree to use reliable methods of contraception during the course of the study

Who cannot join

  • Active hematological disorders other than iron-deficiency anemia
  • Other medical condition that according to the investigator's assessment is causing or contributing to anemia
  • Active malignancy
  • Active infectious disease
  • Active bleeding
  • Severe renal insufficiency (requiring dialysis)
Show all 14Show fewer
  • Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
  • Ongoing oral or intravenous iron supplementation
  • Concomitant erythropoietin medication
  • Pregnancy or lactation period
  • Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study.
  • Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
  • Known haemochromatosis or other iron overload syndromes
  • Patients who have been receiving repeated (>1) blood transfusions during the past 6 months

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)

    Hanover, 30625

Other trials in Germany

About this study

Official title: A Phase IV Study to Explore the Safety of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)

This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.

Being tested
Ferric maltol 30 mg (Feraccru®)
Keywords
Iron Deficiency
Medical subject headings
Heart Failure, Anemia, Iron-Deficiency, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric maltol 30 mg (Feraccru®)Drug

    Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects

Study groups in NCT03774615
Study groupRoleWhat they receive
Ferric maltol 30 mg (Feraccru®)ExperimentalTreatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks
Receives: Drug: Ferric maltol 30 mg (Feraccru®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To detect AEs and SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks

    Measured: baseline to week 12

Secondary outcomes (14)

  1. Change in hemoglobin level from baseline to week 12

    Measured: baseline to week 12

  2. Change in hemoglobin level from baseline to week 6

    Measured: baseline to week 6

  3. Change in serum ferritin levels and transferrin saturation from baseline to week 6

    Measured: baseline to week 6

  4. Change in serum ferritin levels and transferrin saturation from baseline to week 12

    Measured: baseline to week 12

  5. Change in 6 min walking distance from baseline to week 12

    Measured: baseline to week 12

  6. Change in serum NT-proBNP from baseline to weeks 6

    Measured: baseline to weeks 6

  7. Change in serum NT-proBNP from baseline to weeks 12

    Measured: baseline to weeks 12

  8. Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)

    Measured: change from baseline to week 12

  9. Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left atrial area, left ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)

    Measured: change from baseline to week 12

  10. Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12

    Measured: from baseline to week 12

  11. Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6

    Measured: from baseline to week 6

  12. Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12

    Measured: from baseline to week 12

  13. Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6

    Measured: from baseline to week 6

  14. Change in NYHA from baseline to week 12

    Measured: from baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2018
  2. Study start18 Mar 2019
  3. Primary completion29 Nov 2019
  4. Study completion29 Nov 2019

Why it stopped: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open-label, uncontrolled, monocenter, phase IV study
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03774615
Sponsor's protocol ID
ORION-LVAD-1
Acronym
ORION-LVAD-1
Status last verified
Mar 2019
First submitted
12 Dec 2018
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferric maltol 30 mg (Feraccru®) in people with Heart Failure, Left Sided and Anemia, Iron Deficiency, run by Hannover Medical School at 1 site in Germany.

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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To detect AEs and SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks (time frame: baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03774615.

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 21 Apr 2020.

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