ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)

NCT05697211 | Completed Phase 4

• 1 other identifier: ORION-HF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.

Conditions

Heart Failure, Left-sided; Anemia, Iron Deficiency

Keywords

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in haemoglobin level from baseline to week 16

  baseline to week 16

Secondary Outcomes (23)

• Change in serum ferritin from baseline to week 16

  baseline to week 16

• Change in transferrin saturation from baseline to week 16

  baseline to week 16

• Change in soluble transferrin receptor 1 from baseline to week 16

  baseline to week 16

• Change in 6 min walking distance from baseline to week 16

  baseline to week 16

• Change in Health-related quality of life (HRQoL, measured by KCCQ-12) from baseline to week 16

  baseline to week 16

Other Outcomes (2)

• Incidence of treatment-emergent adverse events (AEs)

  up to Week 20

• Incidence of Adverse Events

  up to Week 20

Study Arms (1)

Feraccru® 30 mg hard capsules

EXPERIMENTAL

Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily p.o., morning and evening, on an empty stomach

Drug: Ferric maltol 30 mg (Feraccru®)

Interventions

Ferric maltol 30 mg (Feraccru®) DRUG

In this trial 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.

Feraccru® 30 mg hard capsules

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
• Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
• Patients with chronic heart failure with an Left ventricular ejection fraction (LVEF)\<50% (Heart failure with reduced ejection fraction (HFrEF), Heart failure with a mid-range ejection fraction (HFmrEF)) or patients with chronic heart failure with an EF≥50% (HFpEF) and New York Heart Association functional class II-IV
• min walk distance \>50 m
• Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin concentration ≥8 g/dl and \<12 g/dl in females or ≥9 g/dl and \<13 g/dl in males, and serum ferritin \<100 µg/l, or 100-299 µg/l and transferrin saturation \<20% at screening
• \*Women without childbearing potential defined as follows:
• females before menarche (if applicable)
• at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
• hysterectomy or uterine agenesis or
• ≥ 50 years and in postmenopausal state \> 1 year or
• \< 50 years and in postmenopausal state \> 1 year with serum Follicle stimulating hormone (FSH) \> 40 IU/l and serum estrogen \< 30 ng/l or a negative estrogen test, both at screening or
• \*Women of childbearing potential:
• who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
• who have sexual relationships with female partners only and/or with sterile male partners or
• who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception\*\* from the time of screening until end of the clinical trial.

You may not qualify if:

• Active haematological disorders other than anaemia and/or iron -deficiency
• Other medical condition that according to the investigator's assessment is causing or contributing to anaemia
• Active malignancy or currently receiving chemotherapy or radiotherapy
• Active infectious disease
• Active bleeding
• Severe renal insufficiency (glomerular filtration rate (GFR) \< 20ml/min or requiring dialysis)
• 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
• Erythropoiesis stimulating agents (ESA), i.v. iron or blood transfusion administered in last 3 months and oral iron (\>100 mg/day) in previous 4 weeks
• 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 with severe, uncorrected valvular heart disease

Sponsors & Collaborators

• Hannover Medical School: lead
• Norgine: collaborator

Study Sites (1)

Hannover Medical School, Department of Cardiology and Angiology

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Heart Failure; Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferric maltol

Condition Hierarchy (Ancestors)

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

Study Officials

• Johann Bauersachs, Prof. Dr.

  Hannover Medical School, Department of Cardiology and Angiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: January 25, 2023
• Study Start: February 21, 2023
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)