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Iron Isomaltoside and Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

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ClinicalTrials.gov Identifier: NCT02940886
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects suffering from IDA

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Iron isomaltoside Drug: Iron sucrose Phase 3

Detailed Description:

IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.

This study is designed to evaluate the safety and efficacy of iron isomaltoside compared to iron sucrose in subjects suffering from IDA. In a subfraction of 35 subjects treated with iron isomaltoside ECG and iron will be measured frequently


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (Ferwon IDA)
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Iron isomaltoside (Monofer)
Administered iv
Drug: Iron isomaltoside
Active Comparator: Iron sucrose (Venofer)
Administered iv
Drug: Iron sucrose



Primary Outcome Measures :
  1. The primary safety outcome measure is the incidence of protocol defined hypersensitivity reactions (number of participants with such events ) [ Time Frame: 8 weeks ]
  2. The primary efficacy outcome is the ability to increase Hb (g/dL). [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Protocol defined cardiovascular adverse events (number of participants with such events), [ Time Frame: 8 weeks ]
  2. Changes in S- Ferritin (ng/mL) [ Time Frame: 8 weeks ]
  3. Changes in Transferrin saturation (%) [ Time Frame: 8 weeks ]


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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 includes:

  1. Men or women ≥ 18 years
  2. Subjects having IDA caused by different etiologies
  3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
  4. Hb ≤ 11 g/dL
  5. TSAT < 20 %
  6. S-ferritin < 100 ng/mL
  7. Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

  1. Anemia predominantly caused by factors other than IDA
  2. Hemochromatosis or other iron storage disorders
  3. Previous serious hypersensitivity reactions to any IV iron compound
  4. Erythropoiesis stimulating agent (ESA) treatment
  5. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
  6. Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
  7. Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal
  8. Required dialysis for treatment of CKD
  9. Alcohol or drug abuse within the past 6 months
  10. Pregnant or nursing women

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): NCT02940886


Contacts
Contact: Lars L Thomsen, MD +4559485959 info@pharmacosmos.com

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

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02940886     History of Changes
Other Study ID Numbers: P-Monofer-IDA-03
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics