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

National Cancer Center (NCC)

Status and phase: Completed; Phase 2

Conditions: Anemia; Pancreatic Cancer

Treatments: Drug: Ferinject (Ferric Carboxymaltose)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02628860

NCCCTS-13-709

Details and patient eligibility

About

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

Full description

Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).

Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ferinject

Experimental group

Description:

Ferinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight \<50 Kg . Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride. Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.

Treatment:

Drug: Ferinject (Ferric Carboxymaltose)