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Trial record 2 of 383 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT03774615
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Shields, Shields and Associates
Information provided by (Responsible Party):
Hannover Medical School

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03774615 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
  • Change in hemoglobin level from baseline to week 12 [ Time Frame: baseline to week 12 ]
  • Change in hemoglobin level from baseline to week 6 [ Time Frame: baseline to week 6 ]
  • Change in serum ferritin levels and transferrin saturation from baseline to week 6 [ Time Frame: baseline to week 6 ]
  • Change in serum ferritin levels and transferrin saturation from baseline to week 12 [ Time Frame: baseline to week 12 ]
  • Change in 6 min walking distance from baseline to week 12 [ Time Frame: baseline to week 12 ]
  • Change in serum NT-proBNP from baseline to weeks 6 [ Time Frame: baseline to weeks 6 ]
  • Change in serum NT-proBNP from baseline to weeks 12 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: change from baseline to week 12 ]
  • Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 12 [ Time Frame: from baseline to week 12 ]
  • Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 6 [ Time Frame: from baseline to week 6 ]
  • Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 12 [ Time Frame: from baseline to week 12 ]
  • Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 6 [ Time Frame: from baseline to week 6 ]
  • Change in NYHA from baseline to week 12 [ Time Frame: from baseline to week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
open-label, uncontrolled, monocenter, phase IV study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure, Left Sided
  • Anemia, Iron Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: Ferric maltol 30 mg (Feraccru®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan Schmitto, Prof. MD +49 511 532 ext 3373 Schmitto.Jan@mh-hannover.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774615
Other Study ID Numbers  ICMJE ORION-LVAD-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hannover Medical School
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE Shields, Shields and Associates
Investigators  ICMJE
Principal Investigator: Jan Schmitto, Prof. MD Hannover Medical School
PRS Account Hannover Medical School
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP