Methemoglobinemia Following Intravenous Iron Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Side Effect; Methemoglobinemia; Iron Deficiencies
• Intervention / Treatment: Diagnostic test: Blood sample after treatment; Other: Case reports

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • Center of Clinical Research Dalarna
    • Contact: Claudia Seiler, MD; Phone Number: +46 70 2896416; Email: claudia.seiler@regiondalarna.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ferric derisomaltose; Adult patients with anemia scheduled for administration of ferric derisomaltose as prescribed in routine care.	Diagnostic test: Blood sample after treatment; Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration.
Ferric carboxymaltose; Adult patients with anemia scheduled for administration of ferric carboxymaltose as prescribed in routine care.	Diagnostic test: Blood sample after treatment; Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration.
Case reports; Patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose.	Other: Case reports; Description of clinical course and methemoglobin levels in patients with severe anemia who developed methemoglobinemia after intravenous administration of ferric derisomaltose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in methemoglobin depending on drug dosage	Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on drug dosage	30-120 minutes after start of iron administration
Difference in methemoglobin depending on age	Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on age.	30-120 minutes after start of iron administration
Difference in methemoglobin depending on sex	Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on sex.	30-120 minutes after start of iron administration
Difference in methemoglobin depending on hemoglobin level before treatment	Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron 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.	Change of methemoglobin (percent) in venous blood after compared to before treatment with intravenous iron depending on blood levels of ferritin, transferrin or iron.	30-120 minutes after start of iron administration
Association between difference in methemoglobin and venous lactate	Association between change of methemoglobin (percent) in venous blood and change of lactate in venous blood after compared to before treatment with intravenous iron.	30-120 minutes after start of iron administration

Collaborators and Investigators

• Sponsor: Claudia Seiler

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ferric carboxymaltose; Intravenous iron; ferric derisomaltose
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Anemia; Methemoglobinemia; Iron Deficiencies
• Other Study ID Numbers: MetHb 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No