Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

NCT05251493 | Recruiting Phase 3

• 1 other identifier: HC6-024-c260086 SHA REB-21-64
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion. The goal of this clinical trial:

• Correct IDA with fewer visits and less impact on the healthcare system
• Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.

Conditions

Iron Deficiency Anaemia in Childbirth

Keywords

quality of life; anemia

Outcome Measures

Primary Outcomes (3)

• Correction of anemia

  defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre) for all participants

  30 days post iron infusion

• Correction of anemia

  defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre), all participants of clinical trial

  at delivery admission

• Correction of anemia

  defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre), all participants

  6 week post partum visit

Secondary Outcomes (5)

• Participant's tolerance to IV iron infusion

  Collected at delivery admission survey

• Comparison of participant's pregnancy related symptoms- subjective measure

  collected from baseline, at delivery and 6 weeks postpartum

• Convenience/barriers of IV iron appointment(s)- subjective measure

  collected at delivery admission, post iron infusion

• Changes in Participant's Mental Health and Physical Well-Being

  baseline (at intake), post iron infusion (1 week after infusion), at delivery, at 6 weeks post partum

• Reported bonding with baby-subjective

  collected at 6 weeks postpartum

Study Arms (2)

Iron Isomaltoside/ferric derisomaltose

ACTIVE COMPARATOR

route: intravenous Dosage: 1000-1500 mg (100mg/mL), max dose 20mg/kg Frequency: max dose 1000 mg, if further doses required, must receive dosage divided Duration: one infusion or two infusions (dose dependent)

Drug: Iron Isomaltoside 1000, ferric derisomaltose

Iron Sucrose

ACTIVE COMPARATOR

Route: Intravenous Dosage: 100 mg/mL (maximum 300 mg per dose) Frequency: up to 3 doses per week or 1000 mg per week maximum Duration: until iron needs reached by simplified table

Drug: Iron sucrose

Interventions

Iron Isomaltoside 1000, ferric derisomaltose DRUG

iron isomaltoside 20 mg/mL

Also known as: Monoferric DIN 22477777

Iron Isomaltoside/ferric derisomaltose

Iron sucrose DRUG

iron sucrose 100 mg/mL

Also known as: iron sucrose DIN 02502917

Iron Sucrose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant females with diagnosed iron deficiency anemia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age and over
• Pregnancy with Gestational age ≥13 weeks
• Iron deficiency anemia defined as:
• Hemoglobin less than or equal to 110g/L and
• Serum ferritin less than 30ng/mL or
• Iron Saturation (Iron/TIBC) less than 20%
• Willing to participate and attend all planned follow up visits
• Willing to sign informed consent form
• Willing to attend appointments for iron infusion and follow up visits
• Willing to attend all planned bloodwork appointments

You may not qualify if:

• Pregnancy GA less than 13 weeks
• History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
• Known serious hypersensitivity to other parental iron products
• Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
• Decompensated liver cirrhosis or active hepatitis
• History of multiple allergies
• Active acute or chronic infections
• Current participation in any other interventional trial
• Multiple gestation pregnancy
• Significant comorbidities (asthma requiring daily therapy or other lung diseases)
• Heart disease
• Kidney disease
• Rheumatologic disease
• Cancer
• Known hypersensitivity to iron sucrose or any excipients

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

RECRUITING

Related Publications (8)

• Pavord S, Daru J, Prasannan N, Robinson S, Stanworth S, Girling J; BSH Committee. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2020 Mar;188(6):819-830. doi: 10.1111/bjh.16221. Epub 2019 Oct 2. No abstract available.

  PMID: 31578718 BACKGROUND

• Wesstrom J. Safety of intravenous iron isomaltoside for iron deficiency and iron deficiency anemia in pregnancy. Arch Gynecol Obstet. 2020 May;301(5):1127-1131. doi: 10.1007/s00404-020-05509-2. Epub 2020 Apr 8.

  PMID: 32270330 BACKGROUND

• Congdon EL, Westerlund A, Algarin CR, Peirano PD, Gregas M, Lozoff B, Nelson CA. Iron deficiency in infancy is associated with altered neural correlates of recognition memory at 10 years. J Pediatr. 2012 Jun;160(6):1027-33. doi: 10.1016/j.jpeds.2011.12.011. Epub 2012 Jan 11.

  PMID: 22244466 BACKGROUND

• Pollock RF, Muduma G. A budget impact analysis of parenteral iron treatments for iron deficiency anemia in the UK: reduced resource utilization with iron isomaltoside 1000. Clinicoecon Outcomes Res. 2017 Aug 10;9:475-483. doi: 10.2147/CEOR.S139525. eCollection 2017.

  PMID: 28848355 BACKGROUND

• Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial. Vox Sang. 2017 Apr;112(3):219-228. doi: 10.1111/vox.12477. Epub 2017 Feb 15.

  PMID: 28198084 BACKGROUND

• Khalafallah AA, Dennis AE, Ogden K, Robertson I, Charlton RH, Bellette JM, Shady JL, Blesingk N, Ball M. Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy. BMJ Open. 2012 Oct 18;2(5):e000998. doi: 10.1136/bmjopen-2012-000998. Print 2012.

  PMID: 23087011 BACKGROUND

• Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed., American Psychiatric Association, 2013. doi.org.db29.linccweb.org/10.1176/ appi.

  BACKGROUND

• Duley L, Uhm S, Oliver S; Preterm Birth Priority Setting Partnership Steering Group. Top 15 UK research priorities for preterm birth. Lancet. 2014 Jun 14;383(9934):2041-2042. doi: 10.1016/S0140-6736(14)60989-2. No abstract available.

  PMID: 24931684 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

iron isomaltoside 1000; ferric derisomaltose; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Ryan Lett, MD, FRCPC

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Lett, MD FRCPC

CONTACT

306-766-3491; ryan.lett@saskhealthuauthority.ca

Sarah Smith, MD, BSc

CONTACT

306-352-4963; sarah.Naden.Smith@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Lead Patient Blood Management Department

Model Details: IDA is associated with poor neonatal outcomes and maternal morbidity. This clinical trial will compare IV iron isomaltoside to IV iron sucrose for correction of IDA, along with the potential impacts to the patient: physical, emotional and convenience of attending, receiving and follow up appointments associated with iron infusion. The study will also take into consideration the financial and resource impacts to the healthcare system, and to the patient, and determine the validity of using iron isomaltoside and iron sucrose in second and third trimester pregnancy.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 22, 2022
• Study Start: June 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)