Methemoglobinemia Following Intravenous Iron Treatment

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06309641
• Other study ID #: MetHb 001
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Dalarna County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Methemoglobinemia
• Side Effect

Intervention

Diagnostic Test:
• Blood sample after treatment
Blood samples for measurement of methemoglobin are obtained directly before and 30-120 minutes after drug administration.

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

Locations

Country	Name	City	State
Sweden	Center of Clinical Research Dalarna	Falun

Sponsors (1)

Lead Sponsor	Collaborator
Claudia Seiler

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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