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The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02599012
Recruitment Status : Unknown
Verified February 2017 by Jun Ho Jang, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : November 6, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Jun Ho Jang, Samsung Medical Center

Study Description
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Brief Summary:
  • Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
  • Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
  • Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
  • In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.

Condition or disease Intervention/treatment Phase
Cancer Anemia Drug: Ferinject® Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 12, 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects Drug: Ferinject®
intravenous Ferinject 1000mg injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Hemoglobin response [ Time Frame: visit 4th after Ferinject injection ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who diagnosed with solid cancer or lymphoma

  • Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment

    • anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"
  • Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment

Exclusion Criteria:

  • Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment
  • Subjects with uncontrolled infection
  • Subjects with ongoing bleeding
  • Deteriorated organ function
  • poor performance state (ECOG 3-4)
  • Subjects whose disease involves bone marrow
  • Ferritin > 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%
Contacts and Locations
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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): NCT02599012


Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Irwon-ro ,Kangnam-gu, Korea, Republic of, 06351
Contact: JiYoung Choi    82-2-3410-3660    jy210.choi@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jun Ho Jang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02599012    
Other Study ID Numbers: 2015-01-011-001
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases