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

NCT03774615 | Terminated Phase 4

• 1 other identifier: ORION-LVAD-1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Left Sided; Anemia, Iron Deficiency

Keywords

Iron Deficiency

Outcome Measures

Primary Outcomes (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

  baseline to week 12

Secondary Outcomes (14)

• 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

Study Arms (1)

Ferric maltol 30 mg (Feraccru®)

EXPERIMENTAL

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®)

Interventions

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

Ferric maltol 30 mg (Feraccru®)

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 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 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Shields, Shields and Associates: collaborator

Study Sites (1)

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

Hanover, 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

• Jan Schmitto, Prof. MD

  Hannover Medical School

  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

Model Details: open-label, uncontrolled, monocenter, phase IV study

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 13, 2018
• Study Start: March 18, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: April 21, 2020

Record last verified: 2019-03

Locations

DE (1)