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IV iron drug may cause rare blood disorder, new study investigates

NCT ID NCT06958822

Knowledge-focused Sponsor: Ordu University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at how often a rare blood condition called methemoglobinemia occurs after treatment with the IV iron drug ferric carboxymaltose. Researchers measured methemoglobin levels in nearly 1,000 adults receiving the drug for iron-deficiency anemia and compared them to healthy controls. The goal was to better understand the risk of this potentially serious side effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ferric carboxymaltose (IV iron)
What this could lead to
If this study finds a clear link, it could help doctors monitor for methemoglobinemia and make IV iron therapy safer.
What could go wrong
This is an observational study, not a controlled trial, so it can't prove cause and effect. The condition is rare and usually mild, so the findings may not change practice.

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

977 people

The number who actually took part.

Started

Apr 2025

Finished

Sep 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

Study participants will consist of persons admitted to a total of 21 different secondary or tertiary care hospitals in 16 different provinces across Turkey.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: FCM Group: 1. Adults (≥18 years) 2. Presence of anemia (Hb \<12 g/dl in women, \<13 g/dl in men) 3. Low ferritin (\<30 mcg/l) 4. Patients for whom FCM administration has been decided in routine medical care practice Control Group: Healthy adult (≥18 years) individuals who applied to the internal medicine outpatient clinic, who had no current or pre-existing chronic disease, who did not have anemia and iron deficiency (ferritin ≥30 mcg/L). EXCLUSION CRITERIA: 1. Known methemoglobinemia-related diseases (Hb M disease, cytochrome b5 reductase deficiency, etc.) 2. Use of drugs associated with methemoglobinemia (acetylsalicylic acid, dapsone, chloroquine, metoclopramide, benzocaine, lidocaine, prilocaine, rasburicase, primaquine, sulfonamide, nitric oxide) 3. Those with B12 and/or folate deficiency 4. Those with Charlson Comorbidity Index ≥3 5. Presence of advanced organ failure (Stage 4 and 5 chronic kidney disease, Child C cirrhosis, NYHA class 3 and 4 chronic heart failure, respiratory failure requiring oxygen supplementation and similar processes) 6. Presence of malignancy (with or without cure) 7. Presence of active infection (CRP \> 5 mg/dL) and/or other acute disorder/disease 8. Pregnancy status

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Conditions

The condition(s) this trial relates to.

iron deficiency anemia methemoglobinemia

As listed by the trial registrant

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

Anemia, iron-deficiency Ferric carboxymaltose Methemoglobinemia Parenteral iron therapy

Contacts and locations

Locations

  • Akdeniz University Hospital

    Konyaalti, Antalya, 07070, Turkey (Türkiye)

  • Antalya City Hospital

    Antalya, Kepez, 07080, Turkey (Türkiye)

  • Balıkesir University Health Practice and Research Hospital

    Merkez, Balıkesir, 10145, Turkey (Türkiye)

  • Bursa City Hospital

    Nilufer, Bursa, 16110, Turkey (Türkiye)

  • Bursa Kestel State Hospital

    Bursa, Kestel, 16450, Turkey (Türkiye)

  • Bursa Yuksek Ihtisas Training and Research

    Bursa, Yıldırım, 16310, Turkey (Türkiye)

  • Izmir Bakircay University Cigli Training and Research Hospital

    Çiğli, İzmir, 35610, Turkey (Türkiye)

  • Karabuk University Training and Research Hospital

    Karabük, Karabük Province, 78100, Turkey (Türkiye)

  • Kayseri City Hospital

    Kocasinan, Kayseri, 38080, Turkey (Türkiye)

  • Mardin Artuklu University Training and Research Hospital

    Merkez, Mardin, 47100, Turkey (Türkiye)

  • Mardin Kızıltepe State Hospital

    Mardin, Kızıltepe, 47400, Turkey (Türkiye)

  • Marmara University Training and Research Hospital

    Pendik, Istanbul, 34890, Turkey (Türkiye)

  • Mehmet Yılmaz Aydınlar Acıbadem University

    Ataşehir, Istanbul, 34758, Turkey (Türkiye)

  • Ordu University Training and Research Hospital

    Altinordu, Ordu, 52200, Turkey (Türkiye)

  • Recep Tayyip Erdoğan University Faculty of Medicine Training and Research Hospital

    Rize, Rize Province, 53100, Turkey (Türkiye)

  • Sakarya University Training and Research Hospital

    Adapazarı, Sakarya, 54100, Turkey (Türkiye)

  • Siirt University Faculty of Medicine Training and Research Hospital

    Siirt, Siirt, 56100, Turkey (Türkiye)

  • Umraniye Training and Research Hospital

    Ümraniye, Istanbul, 34764, Turkey (Türkiye)

  • University of Health Sciences Adana City Health Application and Research Center

    Adana, Adana, 01100, Turkey (Türkiye)

  • University of Health Sciences Diyarbakır Gazi Yaşargil Training and Research Hospital

    Kayapınar, Diyarbakır, 21070, Turkey (Türkiye)

  • Van Yüzüncü Yıl University Training and Research Hospital

    Merkez, Van, 65000, Turkey (Türkiye)

  • Çankırı State Hospital

    Çankırı, Çankırı, 18100, Turkey (Türkiye)

  • Çorlu Vatan Hospital

    Tekirdağ, Çorlu, 59850, Turkey (Türkiye)

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