Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®



Status:Active, not recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:July 2015
End Date:December 2018

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IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults

Phase III, multicenter, randomized, double-blinded, prospective study with two parallel
treatment groups. Patients who present to the hematologist/oncologist and satisfy all
inclusion and exclusion criteria will be eligible for participation in this 18-week study.

This is a Phase III, multicenter, randomized, double-blinded, prospective study with two
parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy
all inclusion and exclusion criteria will be eligible for participation in this 18-week
study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized
into the trial (Group A or B).

Inclusion Criteria:

- Subjects (male of female) ≥ 18 years of age able to give informed consent to the
study.

- Subjects with non-myeloid malignancies

- Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of
treatment remaining.

- Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.

- Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%

- Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of
0-2.

- Life expectancy of at least 6 months.

- Demonstrate the ability to understand the requirements of the study, willingness to
abide by study restrictions and to return for the required assessments.

Exclusion Criteria:

- Previous participation in a ferric carboxymaltose clinical trial.

- Known hypersensitivity reaction to any component of ferric carboxymaltose.

- Subjects with overt bleeding

- Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion,
or erythropoiesis-stimulating agents).

- Subjects on erythropoiesis-stimulating agents.

- Requiring dialysis for the treatment of chronic kidney disease.

- Any non-viral infection.

- Known positive hepatitis with evidence of active disease.

- Received an investigational drug within 30 days of screening.

- Alcohol or drug abuse within the past 6 months.

- Hemochromatosis or other iron storage disorders.

- Any other laboratory abnormality, medical condition or psychiatric disorders which in
the opinion of the Investigator would put the subject's disease management at risk or
may result in the subject being unable to comply with study requirements.

- Pregnant or actively trying to become pregnant (Female subjects who are of
childbearing age must have a negative pregnancy test at screening and be practicing an
acceptable method of birth control during the study).
We found this trial at
29
sites
Rockford, Illinois 61108
Phone: 815-227-2674
1667
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Rockford, IL
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
2438
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Bronx, NY
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Phone: 252-559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
2282
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Kinston, NC
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Ashland, Kentucky 41101
Phone: 606-836-0202
1981
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Ashland, KY
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Bethesda, Maryland 20817
Phone: 240-482-0556
2277
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Bethesda, MD
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Boynton Beach, Florida 33426
2308
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Boynton Beach, FL
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Bronx, New York 10469
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Bronx, NY
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Brooklyn, New York 11212
Phone: 718-240-5807
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Brooklyn, NY
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Cary, North Carolina 27511
Phone: 919-223-8566
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Cary, NC
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Charleston, South Carolina 29403
Phone: 843-266-0694
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Charleston, SC
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Corona, California 92879
Phone: 714-698-0303
30
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Corona, CA
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Fountain Valley, California 92708
Phone: 714-698-0300
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Fountain Valley, CA
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Gettysburg, Pennsylvania 17325
Phone: 717-334-5599
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Gettysburg, PA
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Hagerstown, Maryland 21740
Phone: 301-797-8279
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Houston, Texas 77042
Phone: 713-523-6700
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Houston, TX
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Joliet, Illinois 60435
Phone: 815-730-3098
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Joliet, IL
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Lafayette, Indiana
Phone: 765-446-5111
1757
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Lafayette, IN
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Miami Lakes, Florida 33014
Phone: 786-362-5763
2311
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Miami Lakes, FL
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Miami Lakes, Florida 33014
Phone: 786-615-0780
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Miami Lakes, FL
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Midlothian, Virginia 23114
Phone: 804-893-8611
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Midlothian, VA
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Normal, Illinois 61761
Phone: 305-452-9701
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Normal, IL
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Riverside, California 92501
Phone: 951-276-2760
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Riverside, CA
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Rock Hill, South Carolina 29732
Phone: 803-329-7772
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Rock Hill, SC
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South Bend, Indiana 46628
Phone: 574-234-6485
1798
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South Bend, IN
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615 N Michigan Street
South Bend, Indiana 46601
(574) 647-7370
Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
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South Bend, IN
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Staten Island, New York 10310
Principal Investigator: Mahmoud H Aly, MD
Phone: 718-818-2707
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Staten Island, NY
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Tampa, Florida 33612
Phone: 813-844-8712
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Tampa, FL
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Tupelo, Mississippi 38801
Phone: 662-377-4629
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Tupelo, MS
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Winter Haven, Florida 33880
Phone: 863-293-1191
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Winter Haven, FL
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