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Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency Anaemia in Pregnancy.

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ClinicalTrials.gov Identifier: NCT03188445
Recruitment Status : Not yet recruiting
First Posted : June 15, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency anaemia in pregnancy

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia of Pregnancy Drug: Iron Isomaltoside 1000 Drug: ferrous fumarate with ascorbic acid Phase 4

Detailed Description:

Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is de-fined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (<11.0 g/dL in 1st trimester, <10.5 g/dL in 2nd, and <10.5 - 11.0 g/dL in 3rd trimesters).

In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb <11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women.

This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of anaemia in pregnant women who have IDA after 4 weeks of standard treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency Anaemia in Pregnancy: a Randomised, Comparative, Open-label Trial
Anticipated Study Start Date : June 30, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IV administration
Iron isomaltoside (Monofer) Administered iv
Drug: Iron Isomaltoside 1000
Administered iv
Active Comparator: Oral administration
Ferrous fumarate with ascorbic acid Administered oral
Drug: ferrous fumarate with ascorbic acid
Oral administration



Primary Outcome Measures :
  1. The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL [ Time Frame: At any time point within 6 weeks after beginning of treatment with trial drugs ]

Secondary Outcome Measures :
  1. Time to response (achieve an hemoglobin equal to or above 11 g/dL) [ Time Frame: from 6 weeks to 18 weeks ]
  2. Achievement of an hemoglobin equal to or above 11 g/dL [ Time Frame: T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks ]
  3. Change in hemoglobin [ Time Frame: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

A subject will be eligible for inclusion in the trial if she fulfils the following criteria:

  1. Women aged ≥18 years
  2. Pregnancy at GA 14 (+ 2 w)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged ≥18 years
  2. Pregnancy at GA 14 (+ 2 w)
  3. Hb <10.5 g/dL (6.5 mmol/L) and ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
  4. Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form

Exclusion Criteria:

  1. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia)
  2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  3. Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
  4. Known hypersensitivity to any excipients in the investigational drug products
  5. History of active asthma within the last 5 years
  6. History of multiple allergies
  7. Decompensated liver cirrhosis or active hepatitis (defined as elevated hepatic enzymes (alanine aminotransferase (ALAT)) > 3 times upper limit of normal for a pregnant woman at a given GA)
  8. Active acute or chronic infections (assessed by clinical judgement supplied with White Blood Cells (WBC) and CRP)
  9. Rheumatoid arthritis with symptoms or signs of active inflammation
  10. Treated with IV iron products or blood transfusion within 4 weeks prior to screening
  11. Treated with erythropoietin (EPO) within 4 weeks prior to screening
  12. Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to screening
  13. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
  14. Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symp-toms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
  15. Multiple pregnancies
  16. Inability to read and understand the Danish language

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): NCT03188445


Contacts
Contact: Lars Lykke Thomsen, MD +45 59485959 info@pharmacosmos.com

Locations
Denmark
Copenhagen Not yet recruiting
Copenhagen, Sjaeland, Denmark
Sponsors and Collaborators
Pharmacosmos A/S

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03188445     History of Changes
Other Study ID Numbers: P-Monofer-PREG-01
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferrous fumarate
Ascorbic Acid
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Hematinics