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

Iron Deficiency Anemia of Pregnancy Clinical Trial

Official title:

Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188445
• Other study ID #: P-Monofer-PREG-01
• Status: Completed
• Phase: Phase 4
• Start date: July 11, 2017
• Est. completion date: August 18, 2020

Study information

• Verified date: October 2020
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

Description:

Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined 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 IDA in pregnant women after 4 weeks of standard treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 18, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women aged =18 years

2. Pregnancy at GA 14+0 - 19+0

3. 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. History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)

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. Known decompensated liver cirrhosis or active hepatitis

8. Active acute or chronic infections (assessed by clinical judgement)

9. Rheumatoid arthritis with symptoms or signs of active inflammation

10. Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion

11. Treated with erythropoietin (EPO) within 4 weeks prior to inclusion

12. Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion

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 symptoms 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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia of Pregnancy

Intervention

Drug:
• Iron Isomaltoside 1000
Administered iv
• ferrous fumarate with ascorbic acid
Oral administration

Locations

Country	Name	City	State
Denmark	Phamacosmos Investigational site	Hvidovre	Sjaeland

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL		from baseline to 18 weeks after treatment
Secondary	Achievement of an hemoglobin equal to or above 11 g/dL		T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Secondary	Change in iron biomarkers		From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks