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Completed

NCT Number: NCT06309641

Methemoglobinemia Following Intravenous Iron Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center of Clinical Research Dalarna

Falun, 79182, Sweden

About this study

Methemoglobin is an isoform of hemoglobin without oxygen carrying properties. Higher levels of methemoglobin may impact oxygen transport of the blood and increase the risk of tissue hypoxia. Methemoglobinemia has been reported as side effect of different drugs such as antibiotics or local anesthetics, but not after iron preparations. There is only one case report of increased levels of methemoglobin following intravenous iron therapy.

Patients with anemia due to iron deficiency can be treated with intravenous iron preparations such as ferric carboxymaltose or ferric derisomaltose. Anemia itself reduces oxygen transport of the blood, increasing the risk of tissue hypoxia due to methemoglobinemia in those patients.

This study aims to assess methemoglobinemia following treatment with intravenous iron in patients with anemia. The report will include case reports of patients with severe anemia who developed methemoglobinemia following treatment with ferric derisomaltose. Furthermore, methemoglobin levels are evaluated before and after intravenous iron administration in a cohort of adult patients with anemia who are scheduled to receive ferric carboxymaltose or ferric derisomaltose in routine care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Blood sample after treatment

Diagnostic Test

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

Case reports

Other

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

Primary outcomes

  1. Difference in methemoglobin after ferric derisomaltose

    Time frame: 30-120 minutes after start of iron administration

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

  2. Difference in methemoglobin after ferric carboxymaltose

    Time frame: 30-120 minutes after start of iron administration

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

Secondary outcomes

  1. Difference in methemoglobin depending on drug dosage

    Time frame: 30-120 minutes after start of iron administration

    Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on drug dosage

  2. Difference in methemoglobin depending on age

    Time frame: 30-120 minutes after start of iron administration

    Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on age.

  3. Difference in methemoglobin depending on sex

    Time frame: 30-120 minutes after start of iron administration

    Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on sex.

  4. Difference in methemoglobin depending on hemoglobin level before treatment

    Time frame: 30-120 minutes after start of iron administration

    Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on hemoglobin level before treatment.

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

    Time frame: 30-120 minutes after start of iron administration

    Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on blood levels of ferritin, transferrin or iron.

  6. Association between difference in methemoglobin and venous lactate

    Time frame: 30-120 minutes after start of iron administration

    Association between change of methemoglobin (percent) in venous blood and change of lactate in venous blood after compared to before treatment with intravenous iron.

Sponsors and collaborators

Lead sponsor

Claudia Seiler

Other

Registry information

Official study title

Methemoglobinemia Following Intravenous Iron Treatment Administered as Ferric Carboxymaltose or Ferric Derisomaltose in Patients With Anemia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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