Injectafer (ferric carboxymaltose) / Zeria Pharma, Daiichi Sankyo, CSL Behring - LARVOL DELTA

INFERRCT: Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Wroclaw Medical University | N=2000 ➔ 1000 | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment change • HEOR • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

Auditing a switch from ferinject to ferric derisomaltose for intravenous iron in patients with GI bleed or symptomatic IDA (BSG 2025) - "There were no adverse events reported in our cohort.Conclusions Ferric derisomaltose switch results indicate higher first doses of IV iron with lower need for 2nd dose prescriptions, significantly reducing the burden on day case units to arrange out-patient follow up infusions. However, further work is still needed to improve protocol adherence locally for those that require a single infusion but also for those that need a 2nd dose arranging at follow up."

Clinical • Anemia • Gastroenterology • Hematological Disorders

Hypophosphatemia Following Intravenous Iron in Chronic Kidney Disease (ERA 2025) - "Among available formulations, ferric carboxymaltose (FC) has been shown to induce a more profound and sustained decrease in serum phosphate compared to other formulations such as ferric derisomaltose and iron sucrose...The available intravenous iron formulations were Ferinject 50 mg/mL (FC) and Venofer 20 mg/mL (IS)...This effect is more pronounced until stage 3 and with higher cumulative iron doses, independently of baseline vitamin D and calcium levels. Given its potential clinical implications, routine phosphate monitoring should be considered, especially in patients receiving prolonged or high-dose IVIT."

Anemia • Chronic Kidney Disease • Hematological Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • FGF23

Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients (clinicaltrials.gov) - P=N/A | N=128 | Not yet recruiting | Sponsor: Sindh Institute of Urology and Transplantation

New trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron (clinicaltrials.gov) - P4 | N=1025 | Completed | Sponsor: American Regent, Inc. | Unknown status ➔ Completed

HEOR • Trial completion • Anemia • Hematological Disorders

Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports. (PubMed, Eur J Clin Pharmacol) - "This study reveals that FCM carries SAEs. Providers must weigh the benefits and risks on a case-by-case basis, considering patient-specific factors. Continuous monitoring and further research are crucial for the safe use of FCM in iron deficiency anemia."

Adverse events • Journal • Serious adverse event • Cardiovascular • Dermatology • Hematological Disorders • Hypotension • Immunology • Pain • Renal Disease • Urticaria

Cost-effectiveness Analysis of Ferric Carboxymaltose (Renegy®) for the Treatment of Iron Deficiency Anemia During Pregnancy: The Mexican Social Security Institute (IMSS) Perspective (ISPOR 2025) - "From the IMSS perspective, FCM is a clinically superior and a cost-effective treatment for IDA in pregnant women compared to ISC. Also, FCM offers faster and more significant Hb improvement, better tolerability, and substantial cost savings, solidifying its role as the preferred therapeutic option for managing IDA during pregnancy."

Cost effectiveness • HEOR • Anemia • Hematological Disorders

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed

Trial completion

ENHANCING PREOPERATIVE IRON SUPPLEMENTATION IN LIPOABDOMINOPLASTY: A COMPARATIVE STUDY OF FERRIC CARBOXYMALTOSE AND LIPOSOMAL IRON. (PubMed, Plast Reconstr Surg) - "Intravenous ferric carboxymaltose is a superior strategy for preoperative iron optimization in lipoabdominoplasty, ensuring better perioperative stability, faster recovery, and reduced anemia-related complications compared to oral liposomal iron. Integrating this approach into perioperative protocols could enhance surgical outcomes."

Journal • Aesthetic Medicine • Gastrointestinal Disorder • Hematological Disorders

Intravenous Iron Metabolism in Restless Legs Syndrome (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: American Regent, Inc. | N=36 ➔ 12

Enrollment change • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures (clinicaltrials.gov) - P4 | N=209 | Completed | Sponsor: Istanbul University | Recruiting ➔ Completed | Phase classification: PN/A ➔ P4 | Trial primary completion date: Dec 2024 ➔ Jun 2024

Phase classification • Trial completion • Trial primary completion date • Anemia • Hematological Disorders • Musculoskeletal Diseases • Orthopedics

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

New P1 trial

A cost-effective innovation in anaemia management for paediatric haemodialysis-dependant chronic kidney disease patients (IPNA 2025) - "Following Ferinject® infusion, we observed significant increases in laboratory parameters including haemoglobin level, transferrin saturation and reticulocyte haemoglobin content and levels were maintained at 3-months post-infusion (Figure 1a). Ferinject® demonstrated comparable efficacy to Venofer® in maintaining laboratory parameters (Figure 1b). Strikingly, Ferinject® treatment was associated with significantly decreased number of infusions per month (~ 10-fold) and a significant cost-saving (~ 5-fold) (Figure 1c)."

Clinical • Cost effectiveness • HEOR • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease

Hypoferritinemia Without Anemia Among Reproductive Age Females (clinicaltrials.gov) - P=N/A | N=1331 | Active, not recruiting | Sponsor: Akram Medical Complex | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

POREIIL: Postoperative Replacement of Intraoperative Iron Losses (clinicaltrials.gov) - P4 | N=134 | Completed | Sponsor: Kepler University Hospital | Recruiting ➔ Completed | N=360 ➔ 134 | Trial completion date: Dec 2023 ➔ Jan 2025 | Trial primary completion date: Oct 2023 ➔ Jan 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Association between iron deficiency and fertility. (PubMed, Acta Obstet Gynecol Scand) - "Filling of depleted iron stores was positively associated with conception results (higher number of pregnancies) and pregnancy outcomes (higher live birth rates and lower miscarriage rates), regardless of the assisted reproductive technology method used. Screening of iron status seems to be important in patients seeking help for infertility problems."

Journal • Hematological Disorders • Infertility • Sexual Disorders

Intravenous Iron and High Altitude (clinicaltrials.gov) - P4 | N=24 | Recruiting | Sponsor: United States Army Research Institute of Environmental Medicine

New P4 trial

Tomatophagia Caused by Iron Deficiency Anaemia: A Case Report. (PubMed, Cureus) - "Based on the history and clinical findings, the diagnosis of iron deficiency anaemia and carotenemia was made. The patient's condition improved significantly following a blood transfusion and treatment with ferric carboxymaltose (ferinject)."

Journal • Anemia • Hematological Disorders

ITACS: Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery (clinicaltrials.gov) - P4 | N=1000 | Completed | Sponsor: Bayside Health | Recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Surgery • Trial completion • Trial completion date • Trial primary completion date • Anemia • Cardiovascular • Hematological Disorders

Case Report: High-Dose Ferric Carboxymaltose as an Antianaemic Agent to Avoid Haemotransfusions after Total Hip Replacement. (PubMed, Medicina (Kaunas)) - "This article highlights a case of high-dose ferric carboxymaltose (Ferinject®) for the treatment of perioperative iron deficiency anaemia in a 39-year-old patient with dysplastic coxarthrosis...No side effects such as hypophosphatemia were reported. We believe that, in this clinical case, the patient managed to avoid large intraoperative blood loss and transfusions by using high doses of ferric carboxymaltose."

Journal • Hematological Disorders • Orthopedics • Osteoarthritis • Pain • Renal Disease

IDA-I: Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Dr. Frank Behrens | N=407 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Surgery • Trial withdrawal • Anemia • Cardiovascular • Hematological Disorders

IVORY: IV Iron-induced Hypophosphatemia After RYGB (clinicaltrials.gov) - P4 | N=94 | Recruiting | Sponsor: Lucie Favre | Not yet recruiting ➔ Recruiting

Bariatric surgery • Enrollment open • Renal Disease

COMBINED-HF: IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency (clinicaltrials.gov) - P3 | N=99 | Not yet recruiting | Sponsor: Hospital de Clinicas de Porto Alegre

New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

Hypoferritinemia Without Anemia Among Reproductive Age Females (clinicaltrials.gov) - P=N/A | N=1331 | Active, not recruiting | Sponsor: Akram Medical Complex

New trial • Anemia • Hematological Disorders

FAIR-HFpEF: Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: Charite University, Berlin, Germany | Unknown status ➔ Completed | Phase classification: P2 ➔ P4 | N=200 ➔ 40 | Trial completion date: Jul 2021 ➔ Apr 2024

Enrollment change • Phase classification • Trial completion • Trial completion date • Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders