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

Anemia, Iron Deficiency Clinical Trial

— ORION-LVAD-1  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03774615
• Other study ID #: ORION-LVAD-1
• Status: Terminated
• Phase: Phase 4
• Start date: March 18, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: March 2019
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Heart Failure
• Heart Failure, Left Sided

Intervention

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

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Shields, Shields and Associates

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in hemoglobin level from baseline to week 12		baseline to week 12
Secondary	Change in hemoglobin level from baseline to week 6		baseline to week 6
Secondary	Change in serum ferritin levels and transferrin saturation from baseline to week 6		baseline to week 6
Secondary	Change in serum ferritin levels and transferrin saturation from baseline to week 12		baseline to week 12
Secondary	Change in 6 min walking distance from baseline to week 12		baseline to week 12
Secondary	Change in serum NT-proBNP from baseline to weeks 6		baseline to weeks 6
Secondary	Change in serum NT-proBNP from baseline to weeks 12		baseline to weeks 12
Secondary	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
Secondary	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
Secondary	Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12		from baseline to week 12
Secondary	Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6		from baseline to week 6
Secondary	Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12		from baseline to week 12
Secondary	Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6		from baseline to week 6
Secondary	Change in NYHA from baseline to week 12		from baseline to week 12