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

NCT03188445 | Completed Phase 4

• 1 other identifier: P-Monofer-PREG-01
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

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

  from baseline to 18 weeks after treatment

Secondary Outcomes (2)

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

  T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks

• Change in iron biomarkers

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

Study Arms (2)

IV administration

EXPERIMENTAL

Iron isomaltoside (Monofer) Administered iv

Drug: Iron Isomaltoside 1000

Oral administration

ACTIVE COMPARATOR

Ferrous fumarate with ascorbic acid Administered oral

Drug: ferrous fumarate with ascorbic acid

Interventions

Iron Isomaltoside 1000 DRUG

Administered iv

IV administration

ferrous fumarate with ascorbic acid DRUG

Oral administration

Oral administration

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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+0 - 19+0
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Phamacosmos Investigational site

Hvidovre, Sjaeland, Denmark

Location

Related Publications (2)

• 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.

  PMID: 36107229 DERIVED

• 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.

  PMID: 32843079 DERIVED

MeSH Terms

Interventions

iron isomaltoside 1000; ferrous fumarate; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Pharmacosmos A/S Clinical and Non-clinical Research

  Pharmacosmos A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: July 11, 2017
• Primary Completion: June 26, 2020
• Study Completion: August 18, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)