Ferric Carboxymaltose Methemoglobinemia Study

Summary

Anemia that develops due to iron deficiency is called iron deficiency anemia. This common condition is treated with iron supplements taken either orally or given through an intravenous (IV) infusion. Ferric carboxymaltose (FCM) is one of the widely used, comparably newer IV iron preparations. Recently, several publications have raised the possibility that FCM may be associated with mild elevations in methemoglobin (metHb), a form of hemoglobin that cannot effectively deliver oxygen to tissues.

Methemoglobinemia is a known, though uncommon, side effect of some drugs. While usually mild and self-limiting, in certain cases it can become clinically significant or even life-threatening. This observational study is being conducted across multiple centers to better understand how often methemoglobinemia occurs after administration of FCM. As part of routine care, venous blood samples will be used to measure metHb levels in patients receiving FCM, and these results will be compared with those from individuals not exposed to the drug.

Conditions

• Methemoglobinemia
• Anemia, Iron-Deficiency
• Parenteral Iron Therapy
• Ferric Carboxymaltose

Interventions

DRUG

Ferric Carboxymaltose (FCM)

As this is an observational study, ferric carboxymaltose recipients are determined based on routine medical care practices. The researchers do not define which participants will receive ferric carboxymaltose.

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital

  collaborator OTHER

• Ordu University

  lead OTHER

Principal Investigators

• Muhammet Özbilen, MD · Ordu University Faculty of Medicine

• Gökhan Tazegül, MD · Marmara University

• Volkan Aydın, MD PhD · Marmara University School of Dentistry

• Murat Bahadır, MD · Ordu University Faculty of Medicine, Department of Internal Medicine

• Bilge Ada Özcan, MD · Marmara University Training and Research Hospital

• Mehmet Bankir, MD · University of Health Sciences Adana City Health Application and Research Center

• Mehmet Can Erişen, MD · University of Health Sciences Adana City Health Application and Research Center

• Nurhayat Özkan Sevencan, MD · Karabuk University Training and Research Hospital

• Ceren Çevik, MD · Karabuk University Training and Research Hospital

• Aysel Toçoğlu, MD · Sakarya University Training and Research Hospital

• Sümeyye Çekiç, MD · Sakarya University Training and Research Hospital

• Arzu Denler Kılıç, MD · Çankırı State Hospital

• Mehmet Selim Mamiş, MD · Siirt University Faculty of Medicine Training and Research Hospital

• Necip Nas, MD · Siirt University Faculty of Medicine Training and Research Hospital

• Teslime Ayaz, MD · Izmir Bakircay University Cigli Training and Research Hospital

• Barış Emekdaş, MD · Izmir Bakircay University Cigli Training and Research Hospital

• İhsan Solmaz, MD · University of Health Sciences Diyarbakır Gazi Yaşargil Training and Research Hospital

• Ömer Faruk Alakuş, MD · University of Health Sciences Diyarbakır Gazi Yaşargil Training and Research Hospital

• Kamil Konur, MD · Recep Tayyip Erdoğan University Faculty of Medicine Training and Research Hospital

• Hasan Sözel, MD · Akdeniz University Hospital

• Esin Avşar Küçükkurt, MD · Akdeniz University Hospital

• Hacer Şen, MD · Balıkesir University Health Practice and Research Hospital

• Özge Kama Başçı, MD · Balıkesir University Health Practice and Research Hospital

• Nizameddin Koca, MD · Bursa City Hospital

• Fatih İleri, MD · Bursa City Hospital

• Banu Açmaz, MD · Kayseri City Hospital

• Erdem Aydın, MD · Kayseri City Hospital

• İdris Baydar, MD · Mardin Artuklu University Training and Research Hospital

• Şengül Baran Yerlikaya, MD · Mardin Artuklu University Training and Research Hospital

• Yıldız Okuturlar, MD · Mehmet Yılmaz Aydınlar Acıbadem University

• Sibel Serin Ocak, MD · Umraniye Training and Research Hospita

• Nur Düzen Oflas, MD · Van Yüzüncü Yıl University Training and Research Hospital

• Abdullah Güneş, MD · Van Yüzüncü Yıl University Training and Research Hospital

• Nazire Osmançelebioğlu, MD · Recep Tayyip Erdoğan University Faculty of Medicine Training and Research Hospital

• Ant Uzay, MD · Mehmet Yılmaz Aydınlar Acıbadem University

• Sevgi Gülşen Koç, MD · Antalya City Hospital

• Ayşe Karaduru, MD · Antalya City Hospital

• Gamze Kocaman, MD · Bursa Yuksek Ihtisas Training and Research Hospital

• Ali Erol, MD · Bursa Yuksek Ihtisas Training and Research Hospital

• Mehmet Biricik, MD · Mardin Kiziltepe State Hospital

• Emine Binnetoğlu, MD · Çorlu Vatan Hospital

• Muhammet Fatih Şahin, MD · Bursa Kestel State Hospital

• Ebru Çağrı Çakır Özden, MD · Bursa Kestel State Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-14

Primary Completion

2025-09-30

Completion

2025-09-30

FDA Drug

Yes

Countries

• Turkey (Türkiye)

Study Locations