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

Primary Purpose

Iron Deficiency Anemia of Pregnancy

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Iron Isomaltoside 1000

ferrous fumarate with ascorbic acid

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women aged ≥18 years
Pregnancy at GA 14+0 - 19+0
Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form

Exclusion Criteria:

History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
Known hypersensitivity to any excipients in the investigational drug products
History of active asthma within the last 5 years
History of multiple allergies
Known decompensated liver cirrhosis or active hepatitis
Active acute or chronic infections (assessed by clinical judgement)
Rheumatoid arthritis with symptoms or signs of active inflammation
Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
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
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)
Multiple pregnancies
Inability to read and understand the Danish language

Sites / Locations

Phamacosmos Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV administration

Oral administration

Arm Description

Iron isomaltoside (Monofer) Administered iv

Ferrous fumarate with ascorbic acid Administered oral

Outcomes

Primary Outcome Measures

The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL

Secondary Outcome Measures

Achievement of an hemoglobin equal to or above 11 g/dL

Change in iron biomarkers

Full Information

NCT ID

NCT03188445

First Posted

June 13, 2017

Last Updated

November 11, 2020

Sponsor

Pharmacosmos A/S

1. Study Identification

Unique Protocol Identification Number

NCT03188445

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

June 26, 2020 (Actual)

Study Completion Date

August 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia of Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV administration

Arm Type

Experimental

Arm Description

Iron isomaltoside (Monofer) Administered iv

Arm Title

Oral administration

Arm Type

Active Comparator

Arm Description

Ferrous fumarate with ascorbic acid Administered oral

Intervention Type

Drug

Intervention Name(s)

Iron Isomaltoside 1000

Intervention Description

Administered iv

Intervention Type

Drug

Intervention Name(s)

ferrous fumarate with ascorbic acid

Intervention Description

Oral administration

Primary Outcome Measure Information:

Title

The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL

Time Frame

from baseline to 18 weeks after treatment

Secondary Outcome Measure Information:

Title

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

Title

Change in iron biomarkers

Time Frame

From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

A subject will be eligible for inclusion in the trial if she fulfils the following criteria: Women aged ≥18 years Pregnancy at GA 14+0 - 19+0

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged ≥18 years Pregnancy at GA 14+0 - 19+0 Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form Exclusion Criteria: History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Drug hypersensitivity (i.e. previous hypersensitivity to IV iron) Known hypersensitivity to any excipients in the investigational drug products History of active asthma within the last 5 years History of multiple allergies Known decompensated liver cirrhosis or active hepatitis Active acute or chronic infections (assessed by clinical judgement) Rheumatoid arthritis with symptoms or signs of active inflammation Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion Treated with erythropoietin (EPO) within 4 weeks prior to inclusion Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion 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 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) Multiple pregnancies Inability to read and understand the Danish language

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pharmacosmos A/S Clinical and Non-clinical Research

Organizational Affiliation

Pharmacosmos A/S

Official's Role

Study Director

Facility Information:

Facility Name

Phamacosmos Investigational site

City

Hvidovre

State/Province

Sjaeland

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36107229

Citation

Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.

Results Reference

derived

PubMed Identifier

32843079

Citation

Markova V, Hansen R, Thomsen LL, Pinborg A, Moos T, Holm C. Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial. Trials. 2020 Aug 26;21(1):742. doi: 10.1186/s13063-020-04637-z.

Results Reference

derived

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

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