NCT06309641

Brief Summary

Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 2, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

March 7, 2024

Last Update Submit

December 8, 2025

Conditions

MethemoglobinemiaAnemiaIron DeficienciesSide Effect

Keywords

Intravenous ironferric carboxymaltoseferric derisomaltose

Outcome Measures

Primary Outcomes (2)

  • Difference in methemoglobin after ferric derisomaltose

    Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric derisomaltose.

    30-120 minutes after start of iron administration

  • Difference in methemoglobin after ferric carboxymaltose

    Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric carboxymaltose.

    30-120 minutes after start of iron administration

Secondary Outcomes (6)

  • Difference in methemoglobin depending on drug dosage

    30-120 minutes after start of iron administration

  • Difference in methemoglobin depending on age

    30-120 minutes after start of iron administration

  • Difference in methemoglobin depending on sex

    30-120 minutes after start of iron administration

  • Difference in methemoglobin depending on hemoglobin level before treatment

    30-120 minutes after start of iron administration

  • Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron.

    30-120 minutes after start of iron administration

  • +1 more secondary outcomes

Study Arms (3)

Ferric derisomaltose

Adult patients with anemia scheduled for administration of ferric derisomaltose as prescribed in routine care.

Diagnostic Test: Blood sample after treatment

Ferric carboxymaltose

Adult patients with anemia scheduled for administration of ferric carboxymaltose as prescribed in routine care.

Diagnostic Test: Blood sample after treatment

Case reports

Patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose.

Other: Case reports

Interventions

Blood sample after treatmentDIAGNOSTIC_TEST

Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration.

Ferric carboxymaltoseFerric derisomaltose
Case reportsOTHER

Description of clinical course and methemoglobin levels in patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose.

Case reports

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults (age ≥ 18 years) with anemia that are scheduled for administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose) in the region of Dalarna, Sweden.

You may qualify if:

  • for patients in the cohort study:
  • anemia
  • prescription of administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose)
  • for patients in the case report:
  • \- patients with severe anemia who developed methemoglobinemia following administration of ferric derisomaltose

You may not qualify if:

  • declined consent
  • known or suspected methemoglobinemia of genetic or other origin
  • previous administration of intravenous iron within one week before study sampling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Clinical Research Dalarna

Falun, 79182, Sweden

Location

MeSH Terms

Conditions

MethemoglobinemiaAnemiaIron Deficiencies

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Claudia Seiler, MD. Consultant anesthesiologist, department of anesthesiology and intensive care medicine Falun hospital

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

September 2, 2024

Primary Completion

October 13, 2025

Study Completion

October 13, 2025

Last Updated

December 9, 2025

Record last verified: 2025-12

Locations

SE(1)