Skip to main content
OpenTrials
Completed

NCT Number: NCT02962648

An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anaemia Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pharmacosmos Investigational Site, Chula Vista, California, United States

Loading trial locations.

About this study

Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.

The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.

This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completed one of the lead-in trials
  • Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
  • Haemoglobin (Hb) of ≤ 11 g/dL
  • Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
  • Willingness to participate and signing the informed consent form (ICF)

Exclusion criteria

  • Intravenous (IV) iron treatment between the lead-in trial and screening
  • During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
  • Received an investigational drug within 30 days of screening
  • Decompensated liver cirrhosis or active hepatitis
  • Pregnant or nursing women.
  • Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements

Treatment and study plan

Iron isomaltoside/ferric derisomaltose

Drug

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.

The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion.

Other names: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®

Primary outcomes

  1. Number of Subjects With Adverse Drug Reactions (ADR)

    Time frame: Baseline to week 26

    Safety

    Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.

Secondary outcomes

  1. Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

    Time frame: Baseline to week 26

    Safety.

    For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity terms that were included in the analysis were those that started or after the first dose of treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: Loss of consciousness; Seizure; Syncope; Unresponsiveness.

    The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).

    Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.

  2. Composite Cardiovascular Adverse Events (AEs)

    Time frame: Baseline to week 26

    Safety

    Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6.

    The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).

    The potential cardiovascular AEs included the following:

    • Death due to any cause
    • Non-fatal myocardial infarction
    • Non-fatal stroke
    • Unstable angina requiring hospitalisation
    • Congestive heart failure requiring hospitalisation or medical intervention
    • Arrhythmias
    • Hypertension
    • Hypotension

    Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.

  3. Time to First Composite Cardiovascular Safety AE

    Time frame: Baseline, week 2, 13, and 26

    Safety

    Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the Clinical Endpoint Adjudication Committee (CEAC), were considered for this endpoint.

    Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.

  4. S-phosphate <2 mg/dL at Any Time From Baseline to Week 26

    Time frame: Baseline to week 26

    Safety

    Results show the number of trial participants and their status of s-phosphate <2 mg/dL, at any time from baseline to week 26.

  5. Change in Hb From Baseline to Week 2, 13, and 26

    Time frame: Baseline, week 2, 13, and 26

    Efficacy.

    Change in Hb from baseline to week 2, 13, and 26.

  6. Change in S-ferritin From Baseline to Week 2, 13, and 26

    Time frame: Baseline, week 2, 13, and 26

    Efficacy.

    Change in s-ferritin from baseline to week 2, 13, and 26.

  7. Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26

    Time frame: Baseline, week 2, 13, and 26

    Efficacy

    Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26.

    TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.

  8. Change in S-iron From Baseline to Week 2, 13, and 26

    Time frame: Baseline, week 2, 13, and 26

    Efficacy.

    Change in s-iron from baseline to week 2, 13, and 26.

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Registry information

Official study title

An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Acronym: FERWON-EXT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2016
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.