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Completed

NCT Number: NCT02628860

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

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

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Key information

Conditions

Pancreatic Cancer Anemia Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferinject (ferric carboxymaltose)

Drug

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

Primary outcomes

  1. Perioperative transfusion rate

    Time frame: from preoperative baseline within the first 7 days after surgery

    To evaluate reducing transfusion rate during perioperative period

Secondary outcomes

  1. 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)

  2. 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)

  3. Adverse event

    Time frame: up to 4-6 weeks after surgery

    assessment of adverse effect with Ferinject® administration

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • JW Pharmaceutical

Registry information

Acronym: FCM

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2015
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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