Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

• Status: Completed
• Trial end date: 2020-04-27
• Target enrollment: 0
• Participant gender: All

Summary

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborator: JW Pharmaceutical
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• ≥19 years old

• anticipating PD

• preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl

• signed written informed consent

Exclusion Criteria:

• a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient

• hypersensitivity to any component of the formulation

• active severe infection/inflammation

• history of transfusion, erythropoietin, >500 mg intravenous iron administration within 4 weeks prior to screening.

• history of acquired iron overload.

• MCV > 95µm3 or TSAT > 35%

• patients with preoperative Hb<7 g/dl

• pregnancy or lactation

• decreased renal function (defined as creatinine clearance <50 L/min/1.73m2calculated by eGFR(MDRD))

• chronic liver disease or increase of liver enzymes (ALT, AST) >5 times the upper limit of normal range