Monofer (iron isomaltoside 1000) / Pharmacosmos - LARVOL DELTA

Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency. (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: China-Japan Friendship Hospital

HEOR • New trial • Anemia • Genetic Disorders • Hematological Disorders • Obesity

Efficacy and safety of intravenous iron supplementation for perioperative iron deficiency anemia: a systematic review and network meta-analysis of randomized controlled trials. (PubMed, J Clin Anesth) - "FCM improves perioperative Hb concentrations and reduces transfusion requirements. All intravenous iron preparations demonstrated acceptable safety profiles. Further research is needed to validate these findings and refine perioperative iron supplementation strategies."

Journal • Retrospective data • Review • Anemia • Fatigue • Hematological Disorders • Immunology • Pulmonary Disease • Renal Disease

IRONMETHFpEF: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF) (clinicaltrials.gov) - P4 | N=66 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

Pediatric Intravenous Iron Therapy: Evaluating the Safety and Efficacy of Iron Isomaltoside and Low-Molecular-Weight Dextran. (PubMed, Pediatr Blood Cancer) - "Our findings suggest that IIM and LMWD are effective and safe IV iron therapies for pediatric ID/IDA. Given the lack of data on the safety and efficacy of IIM in the pediatric population, our findings provide valuable preliminary evidence."

Journal • Hematological Disorders • Pediatrics

Determination of free iron content in pharmaceutical products containing different iron complexes by using polarography method: "Method development and validation study". (PubMed, J Pharm Sci) - "Iron carbohydrate complexes such as iron gluconate, iron sucrose, ferric carboxy-maltose, iron isomaltoside, ferumoxytol, and iron dextrans, which have been used in the treatment of iron deficiency anemia for many years, release excess iron into the circulation and produce free iron, which leads to oxidative stress and tissue damage. The critical steps such as the selection process of parameters and analytical conditions and the accuracy of the obtained results for the polarography-based analytical method optimization of different pharmaceutical forms are examined by utilizing differential pulse polarography (DPP), which has advantages such as high sensitivity, reproducibility, and detection limits in the determination of different valence ions compared to classical methods. Thus, we aim to shed light on validation processes for the direct determination of free iron in various pharmaceutical formulations, expand the existing literature on the subject, and contribute to..."

Journal • Hematological Disorders

The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: Peking Union Medical College Hospital | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

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

Effectiveness and safety of intravenous iron in ulcerative colitis: A real-world study of impact of disease activity and iron preparations. (PubMed, Indian J Gastroenterol) - "Although there was a tendency towards better response to intravenous iron in those with remission, the findings were not statistically different. Larger studies are needed to provide conclusive evidence. Iron isomaltoside may be preferable over FCM due to risk of hypophosphatemia with the latter."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Renal Disease • Ulcerative Colitis • Venous Ulcer

IVIDA2: Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Women and Infants Hospital of Rhode Island | N=746 ➔ 300

Enrollment change • Anemia • Hematological Disorders

The protective effect of iron isomaltoside on myocardial ischemia-reperfusion injury via the suppression of KLF4/NF-κB signaling. (PubMed, PLoS One) - "Interestingly, the function of IIM on apoptosis, MMP, inflammation and autophagy were abolished by KLF4 overexpression in H/R-induced H9C2 cells. In conclusion, IIM could repress cardiomyocyte apoptosis, inflammation and autophagy through the inhibition of the KLF4/NF-κB pathway and thus reduced myocardial injury in vivo and in vitro."

Journal • Cardiovascular • Inflammation • Myocardial Infarction • Myocardial Ischemia • Reperfusion Injury • KLF4

Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Saskatchewan Health Authority - Regina Area | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

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

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) (clinicaltrials.gov) - P3 | N=82 | Recruiting | Sponsor: AHS Cancer Control Alberta | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Anemia • Gynecologic Cancers • Hematological Disorders • Oncology

Neuroimaging Ancillary Study (clinicaltrials.gov) - P=N/A | N=184 | Completed | Sponsor: Thomas Jefferson University | Active, not recruiting ➔ Completed

Trial completion • Anemia • CNS Disorders • Developmental Disorders • Hematological Disorders • Psychiatry

Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study (clinicaltrials.gov) - P3 | N=30 | Not yet recruiting | Sponsor: Hull University Teaching Hospitals NHS Trust

New P3 trial • Anemia • Hematological Disorders

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age with Iron Deficiency Anemia (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Pharmacosmos A/S | Trial completion date: Jun 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders

Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients (clinicaltrials.gov) - P4 | N=124 | Not yet recruiting | Sponsor: Xie Jingyuan, MD

New P4 trial • Anemia • Hematological Disorders

Anemia in inflammatory bowel disease-A comprehensive review. (PubMed, Indian J Gastroenterol) - "Other causes include vitamin B12 and folate deficiency, hemolytic anemia and medications such as azathioprine and sulfasalazine...However, a significant proportion of IBD patients with anemia go undetected or untreated and there is a need for improved recognition and better management practices. This review discusses various aspects of anemia in IBD and the current approach to diagnosis and management."

Journal • Review • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

POAM: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University Health Network, Toronto | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Jun 2027 | Initiation date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Anemia • Cardiovascular • Hematological Disorders

COMPARATIVE STUDY ON SAFETY AND EFFICACY OF IRON ISOMALTOSIDE VERSUS IRON SUCROSE IN PATIENTS OF ANEMIA IN CHRONIC KIDNEY DISEASE STAGE 3-5 ND (ISN-WCN 2025) - "IIM group showed a significant rise in TSAT over IS group at week 4 and week8 , but showed non inferiority at week 2.In terms of rise in ferritin IIM group showed superiorty over IS group at week 4 and week 8. Conclusions A single dose of IIM showed a better 8-week haematological response (in terms of Hb ,TSAT and serum ferritin ) as compared to multiple doses of IS and also showed low rates of hypersensitivity reactions."

Clinical • Anemia • Chronic Kidney Disease • Hematological Disorders • Immunology • Nephrology • Renal Disease

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department (clinicaltrials.gov) - P3 | N=40 | Recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Oct 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

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

Effect of preoperative combination of low-dose dexamethasone with iron isomaltoside on prognosis of elderly intertrochanteric hip fractures ---- Single-center, randomized, single-blind, blank controlled clinical trial (ChiCTR) - P=N/A | N=160 | Not yet recruiting | Sponsor: Guabgzhou First People‘s Hospital; Guabgzhou First People‘s Hospital

New trial • Musculoskeletal Diseases • Orthopedics

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age with Iron Deficiency Anemia (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Pharmacosmos A/S | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders

A phase III, prospective, open-label, multi-center trial of ferric derisomaltose in children 0 to <18 years of age with iron deficiency anemia due to non-dialysis dependent chronic kidney disease or with iron deficiency anemia who are intolerant or unresponsive to oral iron. (clinicaltrialsregister.eu) - P3 | N=200 | Sponsor: Pharmacosmos A/S

New P3 trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Monoferric for Prenatal Iron Deficiency (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Oregon Health and Science University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Obstetrics

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

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