- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101399
Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy (FID-CHEMO)
Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional Iron Deficiency Receiving Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects (male or female) aged ≥18, suffering from indolent non-Hodgkin's lymphoma, multiple myeloma or chronic lymphocytic leukaemia on any chemotherapy excluding anthracycline containing.
- Life expectancy at least 6 months.
- Received at least 12 weeks (or 3 cycles) of treatment in the current course of chemotherapy before start of iron therapy.
- 8.5 g/dL Hb 10.5 g/dL at time of randomisation.
Iron-restricted erythropoiesis as defined:
- Stainable iron in bone marrow combined with transferrin saturation (TSAT) ≤20% OR
where the evaluation of stainable iron in bone marrow is not possible or available:
- ferritin >30 ng/mL (women) or >40 ng/mL (men) and
- TSAT ≤20%
- Signed informed consent (before any study procedure).
- Females of child-bearing potential must have a negative urine pregnancy test.
Exclusion Criteria:
- Any anaemia treatment within 4 weeks before inclusion (including red blood cell transfusion, ESA treatment and any oral/parenteral iron supplementation).
- Subjects weighing <35 kg.
- Subjects with increase in Hb during the chemotherapy (>1 g/dL rise between initiation of CT and screening laboratory value).
- Folate deficiency (serum folate <4.5 nmol/L) and/or vitamin B12 deficiency (serum cobalamin <145 pmol/L).
- Ongoing haemolysis defined as serum haptoglobin <0.2 g/L.
- Recent significant bleeding/surgery.
- Monotherapy with immunotherapy agents.
- Known chronic renal failure, creatinine >125 μmol/L.
- Anthracycline containing chemotherapy regimens.
- Clinically relevant active inflammatory disease other than the malignant disease (according to the judgement of the Investigator).
- Clinically relevant ongoing infectious disease including known human immunodeficiency virus.
- Serum-ferritin >800 ng/mL.
- Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.
- Significant cardiovascular disease prior to study inclusion including myocardial infarction within 12 months prior to study inclusion, congestive heart failure New York Heart Association (NYHA) Grade III or IV, or poorly controlled hypertension according to the judgment of the Investigator.
- Elevation of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 3 times above the normal range or known acute hepatic disorder.
- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s).
- Females who are evidently pregnant (e.g., positive HCG test) or are breast feeding.
- Subject is not using adequate contraceptive precautions. Adequate contraceptive precautions are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post menopausal, defined as amenorrhea for at least 12 months.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject will not be available for follow-up assessment.
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Local standard of care.
Subjects will be treated according to the local institutional practice.
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Active Comparator: Ferric carboxymaltose
Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy.
In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 4 (week 2).
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Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline. Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2). Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in haemoglobin from baseline to Week 4
Time Frame: Weeks 4 post baseline
|
Weeks 4 post baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment.
Time Frame: 12 weeks post baseline
|
12 weeks post baseline
|
Change in haemoglobin from baseline to Week 6
Time Frame: 6 weeks after baseline
|
6 weeks after baseline
|
Change in haemoglobin from baseline to Week 8
Time Frame: 8 weeks after baseline
|
8 weeks after baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Torbjörn Karlsson, MD, PhD, Capio St Görans Sjukhus, Stockholm
- Study Director: Morgan McNamara, Vifor Pharma, CH-8152 Glattbrugg, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FER-FID-CHEMO
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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Clinical Trials on Ferric carboxymaltose
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Sichuan Huiyu Pharmaceutical Co., LtdThe First Hospital of Jilin University; Suzhou Guochen Biotek Co., Ltd.; Boji... and other collaboratorsCompletedBioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency AnaemiaIron Deficiency | AnaemiaChina
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Hasselt UniversityZiekenhuis Oost-LimburgCompleted
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The Catholic University of KoreaUnknownKnee Osteoarthritis | Total Knee Arthroplasty | Postoperative Anemia
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The Catholic University of KoreaUnknownKnee Osteoarthritis | Total Knee Arthroplasty | Postoperative Anemia
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Charite University, Berlin, GermanyUniversity of GöttingenUnknownHeart Failure | Iron-deficiencyGermany
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St Joseph University, Beirut, LebanonSaint-Joseph University; Vifor PharmaCompletedAnemia, Iron DeficiencyLebanon
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Istanbul UniversityRecruitingAnemia | Hip Fractures | Complication,PostoperativeTurkey
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Vifor PharmaTerminatedIron-Deficiency AnemiaFrance, Greece
-
American Regent, Inc.Completed
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University of ZurichTerminated