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

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

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

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

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Anemia • Hematological Disorders

Retrospective Study Comparing Treatment Outcomes in Obstetric Patients With Iron Deficiency Anemia Treated With and Without Intravenous Ferric Carboxymaltose. (PubMed, Cureus) - "Methods In this study conducted in a large maternity unit in Singapore between 2021 to 2023, we compared the changes in maternal hematological parameters among obstetric patients with iron deficiency anemia presenting to the day care unit in the second or third trimester with a Hb level of <8 g/dl treated with a single dose of ferric carboxymaltose injection (Ferinject) against a control group who were referred for treatment but defaulted on and declined treatment...Conclusion A single injection dose of ferric carboxymaltose as an outpatient antenatal procedure was easily administered and well tolerated. Obstetric patients with iron deficiency anemia who received intravenous ferric carboxymaltose had a significantly higher level of Hb than those who did not."

Journal • Retrospective data • Anemia • Hematological Disorders • Obstetrics

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

Bariatric surgery • New P4 trial • Renal Disease

Ferinject approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure (Canada Newswire) - "CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity. Ferinject has now received marketing authorization in 87 countries worldwide....In Canada, Ferinject is commercialized through CSL Behring Canada, Inc., with availability expected in the second half of 2024."

Canadian regulatory • Launch Canada • Anemia • Hematological Disorders

PREFECO: Preoperative i.v. Iron Substitution in Patients With Colon Cancer (clinicaltrials.gov) - P=N/A | N=514 | Recruiting | Sponsor: Helsinki University Central Hospital | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Anemia • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Oncology • Solid Tumor

IV ferric carboxymaltose (Injectafer) for iron deficiency in heart failure. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

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

VICTORID-HF: Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency (clinicaltrials.gov) - P4 | N=258 | Not yet recruiting | Sponsor: University of Padova | Initiation date: Sep 2023 ➔ Jan 2024

Trial initiation date • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Anemia • Hematological Disorders