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Trial record 33 of 36 for:    pharmacosmos

Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients (IronIC)

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ClinicalTrials.gov Identifier: NCT03662789
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Pharmacosmos A/S
Information provided by (Responsible Party):
Lars Gullestad, Oslo University Hospital

Brief Summary:
Iron deficiency is prevalent in heart transplant recipients, and may be associated with reduced functional capacity. The IronIC trial is designed to assess the effect of intravenous iron isomaltoside on exercise capacity, muscle strength, cognition and quality of life in iron-deficient heart transplant recipients

Condition or disease Intervention/treatment Phase
Heart Transplant Recipients Drug: Iron Isomaltoside 1000 Other: Placebo: NaCl 0,9% Phase 2 Phase 3

Detailed Description:

Iron deficiency is prevalent in patients with heart failure. Iron deficiency is associated with a worse prognosis, and randomised controlled trials have shown that correction of iron deficiency with intravenous iron therapy improves functional capacity, quality of life, and 6-minute walk distance. Current guidelines therefore recommend intravenous iron substitution in patients with heart failure with reduced ejection fraction and iron deficiency. Intravenous iron is more effective, better tolerated, and improves quality of life to a greater extent than oral iron supplements. In the IRONOUT HF trial, in which 225 patients with systolic heart failure were randomised to oral iron supplement or placebo, there was no effect on oxygen uptake, 6-minute walk distance, or quality of life. The authors attributed the negative results to the minimal effect on iron stores, suggesting that oral iron does not adequately replenish iron stores in patients with heart failure.

Cardiac allograft recipients resemble patients with heart failure in many respects. Prior to transplantation, and in some instances after heart transplantation, they have had overt heart failure. Moreover, due to the immunologic challenge posed by the allograft, and their susceptibility to infection due to immunosuppressive treatment, cardiac allograft recipients have low-grade inflammation. This low-grade inflammation makes it difficult to interpret iron stores, and results in dysregulated iron metabolism.

There have been no studies to assess the effect of intravenous iron therapy in heart transplant recipients who have iron deficiency. There is reason to believe that a liberal definition of iron deficiency should be used in cardiac allograft recipients, and the investigators have elected to use the well-established definition used in patients with heart failure: serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %. Because oral iron supplement is less effective then intravenous iron in general, and in patients with heart failure in particular, the investigators assume that oral iron supplement is inadequate in heart transplant recipients. the investigators have designed the IronIC trial to assess the effect of intravenous iron isomaltoside on exercise capacity, muscle strength, cognition and quality of life in iron-deficient heart transplant recipients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo controlled, parallel group, double blind design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Opaque envelopes, infusion administered by third party, concealed infusion
Primary Purpose: Treatment
Official Title: Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : April 14, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Iron isomaltoside 1000
The active drug, iron isomaltoside 1000 will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment).
Drug: Iron Isomaltoside 1000
Intravenous infusion
Other Name: Monofer B03AC-

Placebo Comparator: Placebo
Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%
Other: Placebo: NaCl 0,9%
Intravenous infusion




Primary Outcome Measures :
  1. Peak oxygen consumption [ Time Frame: 6 months after intervention ]
    The primary endpoint will be the baseline-adjusted between-group difference in peak oxygen consumption as measured on a treadmill exercise test


Secondary Outcome Measures :
  1. Iron deficiency [ Time Frame: 6 months after intervention ]
    The number of patients with absolute or functional iron deficiency

  2. Muscle strength [ Time Frame: 6 months after intervention ]
    Baseline-adjusted muscle strength as measured by a hand-grip dynamometer

  3. Body composition [ Time Frame: 6 months after intervention ]
    Body composition measured with the InBody 770 Body Composition Analyzer

  4. Cognitive function [ Time Frame: 6 months after intervention ]
    Baseline-adjusted cognitive function as assessed by the Cambridge Neuropsychological Test Automated Battery

  5. Health related quality of life: SF-36 [ Time Frame: 6 months after intervention ]
    Baseline-adjusted quality of life as assessed with the 36-item short form survey (SF-36), where eight healt consepts are scored by numbers; physical function (1-3), bodily pain (1-5), role limitations due to physical healthproblems (1-5), role limitations due to personal or emotional problems (1-5), emotional well-being (1-5), social function (1-5), energy/fatigue (1-5), and general health perseptions (1-5).

  6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) [ Time Frame: 6 months after intervention ]
    The between-group difference in baseline-adjusted NT-proBNP

  7. C-reactive protein (CRP) [ Time Frame: 6 months after intervention ]
    The between-group difference in baseline-adjusted CRP

  8. Cardiac troponin T (TnT) [ Time Frame: 6 months after intervention ]
    The between-group difference in baseline-adjusted TnT



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac allograft.
  • Presentation at least one year after heart transplantation.
  • Iron deficiency defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.
  • Age between 18 and 80 years.
  • Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations.

Exclusion Criteria:

  • Anaemia (Haemoglobin < 100 mg/l)
  • Haemochromatosis
  • Haemosiderosis
  • Porphyria cutanea tarda
  • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
  • Decompensated liver disease (Child-Pugh score 7 or higher)
  • End-stage renal failure, i.e. estimated glomerular filtration rate < 15 ml/min or on renal replacement therapy
  • Planned cardiac surgery or angioplasty within 6 months
  • Planned major surgery within 6 months
  • Medical history of unresolved cancer (except for basal cell carcinoma)
  • Treatment with systemic steroids more than the equivalent of 10 mg Prednisone/day at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  • Any uncontrolled endocrine disorder except type 2 diabetes
  • Pregnancy
  • On erythropoietin analogues
  • Known sensitivity or intolerance to iron isomaltoside or other parenteral iron preparations
  • Intravenous iron supplement within 6 months prior to inclusion
  • On oral iron substitution (unless the subject agrees to stop treatment prior to randomisation)
  • Ongoing rejections or infections
  • Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
  • Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662789


Contacts
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Contact: Lars Gullestad, MD, PhD 0047 23070000 lars.gullestad@medisin.uio.no
Contact: Kaspar Broch, MD, PhD 0047 92091824 kaspar.broch@ous-hf.no

Locations
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Norway
Oslo university Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0372
Contact: Lars Gullestad, MD, PhD    0047 23070000    lars.gullestad@medisin.uio.no   
Contact: Kaspar Broch, MD, PhD    0047 92091824    sbbrok@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Pharmacosmos A/S
Investigators
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Principal Investigator: Lars Gullestad, MD, PhD Oslo University Hospital

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Responsible Party: Lars Gullestad, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03662789     History of Changes
Other Study ID Numbers: IronIC
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lars Gullestad, Oslo University Hospital:
Heart transplant
Iron deficiency
Intravenous iron supplement
Peak oxygen consumption
Cardiopulmonary exercise test
Cognitive function
Muscle strength
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Iron isomaltoside 1000
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics