ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)

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.

Study Overview

• Status: Terminated
• Conditions: Anemia, Iron Deficiency; Heart Failure, Left Sided
• Intervention / Treatment: Drug: Ferric maltol 30 mg (Feraccru®)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
2. Male and female patients ≥18 years at day of inclusion
3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
4. 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
5. 6 min walk distance >50 m
6. 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
7. 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

Exclusion Criteria:

1. Active hematological disorders other than iron-deficiency anemia
2. Other medical condition that according to the investigator's assessment is causing or contributing to anemia
3. Active malignancy
4. Active infectious disease
5. Active bleeding
6. Severe renal insufficiency (requiring dialysis)
7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
8. Ongoing oral or intravenous iron supplementation
9. Concomitant erythropoietin medication
10. Pregnancy or lactation period
11. 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.
12. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
13. Known haemochromatosis or other iron overload syndromes
14. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ferric maltol 30 mg (Feraccru®); Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks	Drug: Ferric maltol 30 mg (Feraccru®); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	baseline to week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in hemoglobin level from baseline to week 12	baseline to week 12
Change in hemoglobin level from baseline to week 6	baseline to week 6
Change in serum ferritin levels and transferrin saturation from baseline to week 6	baseline to week 6
Change in serum ferritin levels and transferrin saturation from baseline to week 12	baseline to week 12
Change in 6 min walking distance from baseline to week 12	baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6	baseline to weeks 6
Change in serum NT-proBNP from baseline to weeks 12	baseline to weeks 12
Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion)	change from baseline to week 12
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)	change from baseline to week 12
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12	from baseline to week 12
Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6	from baseline to week 6
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12	from baseline to week 12
Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6	from baseline to week 6
Change in NYHA from baseline to week 12	from baseline to week 12

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Shields, Shields and Associates
• Investigators: Principal Investigator: Jan Schmitto, Prof. MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): November 29, 2019
• Study Completion (Actual): November 29, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Iron Deficiency
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Heart Failure; Anemia, Iron-Deficiency; Hematinics; Ferric maltol
• Other Study ID Numbers: ORION-LVAD-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No