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

April 27, 2020 updated by: Sang-Jae Park, National Cancer Center, Korea
This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferinject

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.
Drug: 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 .

Study drug may be administered as IV drip infusion or IV undiluted bolus injection.

Other Names:
  • Ferinject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative transfusion rate
Time Frame: from preoperative baseline within the first 7 days after surgery
To evaluate reducing transfusion rate during perioperative period
from preoperative baseline within the first 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications
Time Frame: up to 4-6 weeks after surgery
To investigate the association between the number of participants with complications and hospital length of stay(days)
up to 4-6 weeks after surgery
Change of hematology parameters
Time Frame: 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)
up to 4-6 weeks after surgery
Adverse event
Time Frame: up to 4-6 weeks after surgery
assessment of adverse effect with Ferinject® administration
up to 4-6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

JW Pharmaceutical

Investigators

  • Principal Investigator: Sang Jae Park, M.D, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 27, 2020

Study Completion (Actual)

April 27, 2020

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-13-709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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