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Iron infusion safety check: rare blood disorder studied in 50 patients

NCT ID NCT06309641

Knowledge-focused Sponsor: Claudia Seiler Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether intravenous iron treatments (ferric carboxymaltose or ferric derisomaltose) can cause a rare side effect called methemoglobinemia, where blood can't carry oxygen properly. Researchers measured methemoglobin levels in 50 anemic patients before and after treatment. The goal was to understand if this side effect occurs and how it relates to drug dose or patient age.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Sep 2024

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anemia Iron Deficiencies methemoglobinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia Iron deficiencies Methemoglobinemia Side effect

Contacts and locations

Locations

  • Center of Clinical Research Dalarna

    Falun, 79182, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.