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An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside (Monofer®) (FerWonExt)

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ClinicalTrials.gov Identifier: NCT02962648
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
Evaluation of safety and efficacy of IV iron isomaltoside re-dosing.

Condition or disease Intervention/treatment Phase
Iron-Deficiency Anemia Drug: Iron Isomaltoside Phase 3

Detailed Description:

Among the various formulations of parenteral iron available on the market, iron isomaltoside may allow flexibility in terms of high and rapid dosing. The use of parenteral iron, especially in high doses, may result in better compliance, fewer visits to the medical practitioner, and overall improvement in QoL.

Most trials with IV iron have been 4-12 weeks trials and long-term trials are warranted to fol-low-up on long-term safety.

This trial is a 6-months extension trial where the aim is to evaluate the safety and efficacy of IV iron isomaltoside re-dosing.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside (Monofer®)
Actual Study Start Date : December 2016
Actual Primary Completion Date : June 12, 2018
Actual Study Completion Date : June 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Iron isomaltoside
Administered IV
Drug: Iron Isomaltoside
Other Name: Monofer




Primary Outcome Measures :
  1. The primary outcome measure is the number of adverse drug reaction (ADR). [ Time Frame: 6 months ]
  2. Change in Hb [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Protocol defined cardiovascular adverse events (number of participants with such events) [ Time Frame: 6 months ]
  2. Change in Ferritin [ Time Frame: 6 months ]
  3. Change in Transferrin saturation (%) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Completed one of the lead-in trials
  2. Randomised and dosed with iron isomaltoside in one of the lead-in trials.
  3. Hb of ≤ 11 g/dL
  4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if TSAT≤ 30 %
  5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

  1. IV iron treatment between the lead-in trial and screening
  2. 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
  3. Received an investigational drug within 30 days of screening
  4. Decompensated liver cirrhosis or active hepatitis
  5. Pregnant or nursing women.
  6. 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

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): NCT02962648


Locations
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United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
Pharmacosmos A/S

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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02962648     History of Changes
Other Study ID Numbers: P-monofer-IDA/CKD-EXT-01
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Keywords provided by Pharmacosmos A/S:
IDA

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs