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

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ClinicalTrials.gov Identifier: NCT02628860
Recruitment Status : Unknown
Verified March 2017 by Sang-Jae Park, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : December 11, 2015
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Sang-Jae Park, 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Anemia Drug: Ferinject (Ferric Carboxymaltose) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
Study Start Date : January 2014
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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 Name: Ferinject




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628860


Contacts
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Contact: Sang Jae Park, M.D +82-31-920-1640 spark@ncc.re.kr
Contact: Sung Sik Han, M.D +82-31-920-1641 sshan@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Sang Jae Park, MD    82-31-920-1640    spark@ncc.re.kr   
Contact: Sung Sik Han, MD    82-31-920-1641    sshan@ncc.re.kr   
Sub-Investigator: Jung Nam Joo, Ph.D         
Sub-Investigator: Sun Young Gong, M.D         
Sub-Investigator: Sung Sik Han, M.D         
Sub-Investigator: Young Woo Kim, M.D         
Sub-Investigator: Woo Jin Lee, M.D         
Sub-Investigator: Sang Myeong Woo, M.D         
Sub-Investigator: Seung Duk Lee, M.D         
Sponsors and Collaborators
National Cancer Center, Korea
JW Pharmaceutical
Investigators
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Principal Investigator: Sang Jae Park, M.D Study Principal Investigator

Publications of Results:

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Responsible Party: Sang-Jae Park, Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02628860     History of Changes
Other Study ID Numbers: NCCCTS-13-709
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sang-Jae Park, National Cancer Center, Korea:
ferric carboxymaltose
Ferinject®
pancreatoduodenectomy
Additional relevant MeSH terms:
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Ferric Compounds
Hematinics