Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients

NCT03662789 | Completed Phase 2 Results DMC

• 1 other identifier: IronIC
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Transplant Recipients

Keywords

Heart transplant; Iron deficiency; Intravenous iron supplement; Peak oxygen consumption; Cardiopulmonary exercise test; Cognitive function; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Consumption

  The primary endpoint will be the baseline-adjusted between-group difference in peak oxygen consumption as measured on a treadmill exercise test

  6 months after intervention

Secondary Outcomes (6)

• Iron Deficiency

  6 months after intervention

• Muscle Strength

  6 months after intervention

• Health Related Quality of Life: SF-36, Physical Component Summary (PCS)

  6 months after intervention

• N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)

  6 months after intervention

• Cardiac Troponin T (TnT)

  6 months after intervention

Study Arms (2)

Iron isomaltoside 1000

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Patients allocated to placebo will receive an intravenous infusion of 100 ml NaCl 0.9%

Other: Placebo: NaCl 0,9%

Interventions

Iron Isomaltoside 1000 DRUG

Intravenous infusion

Also known as: Monofer B03AC-

Iron isomaltoside 1000

Placebo: NaCl 0,9% OTHER

Intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Pharmacosmos A/S: collaborator

Study Sites (1)

Oslo university Hospital, Rikshospitalet

Oslo, 0372, Norway

Location

Related Publications (2)

• Brautaset Englund KV, Ostby CM, Rolid K, Gude E, Andreassen AK, Gullestad L, Broch K. Intravenous iron supplement for iron deficiency in cardiac transplant recipients (IronIC): A randomized clinical trial. J Heart Lung Transplant. 2021 May;40(5):359-367. doi: 10.1016/j.healun.2021.01.1390. Epub 2021 Jan 23.

  PMID: 33612360 BACKGROUND

• Burker BS, Brautaset Englund KV, Myrdal Ostby C, Andersson S, Gullestad L, Broch K. Cognitive Function Among Heart Transplant Recipients Before and After Intravenous Iron Supplement for Iron Deficiency: Results From a Randomized, Placebo-Controlled, Double-Blind Treatment Trial. Clin Transplant. 2025 Nov;39(11):e70370. doi: 10.1111/ctr.70370.

  PMID: 41182019 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Lars Gullestad
• Organization: Oslo University Hospital

lars.gullestad@medisin.uio.no

0047 97644772

Study Officials

• Lars Gullestad, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque envelopes, infusion administered by third party, concealed infusion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, placebo controlled, parallel group, double blind design

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: September 7, 2018
• Study Start: April 25, 2018
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)