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

Phase 2

Completed

• Conditions: Anemia; Pancreatic Cancer
• Interventions: Drug: Ferinject (Ferric Carboxymaltose)

• Registration Number: NCT02628860
• Lead Sponsor: National Cancer Center, Korea

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Status Verified: 2020-04
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ferinject	Ferinject (Ferric Carboxymaltose)	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.

Primary Outcome Measures

Name	Time	Method
Perioperative transfusion rate	from preoperative baseline within the first 7 days after surgery	To evaluate reducing transfusion rate during perioperative period

Secondary Outcome Measures

Name	Time	Method
Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications	up to 4-6 weeks after surgery	To investigate the association between the number of participants with complications and hospital length of stay(days)
Change of hematology parameters	up to 4-6 weeks after surgery	change of hematology parameters value of Hb in g/dL,; * ferritin in ng/ml; * transferrin saturation in % (TSAT) after Ferinject® administration)
Adverse event	up to 4-6 weeks after surgery	assessment of adverse effect with Ferinject® administration

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of