Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients

• Status: Completed
• Trial end date: 2020-02-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: Pharmacosmos A/S
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

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