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

Use our guide to learn which trials are right for you!

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
Normal, Illinois 61761
Phone: 305-452-9701
?
mi
from
Normal, IL
Click here to add this to my saved trials
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...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
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...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
Ashland, Kentucky 41101
Phone: 606-836-0202
?
mi
from
Ashland, KY
Click here to add this to my saved trials
Bethesda, Maryland 20817
Phone: 240-482-0556
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Boynton Beach, Florida 33426
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Bronx, New York 10469
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11212
Phone: 718-240-5807
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Cary, North Carolina 27511
Phone: 919-223-8566
?
mi
from
Cary, NC
Click here to add this to my saved trials
Charleston, South Carolina 29403
Phone: 843-266-0694
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Corona, California 92879
Phone: 714-698-0303
?
mi
from
Corona, CA
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 714-698-0300
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Gettysburg, Pennsylvania 17325
Phone: 717-334-5599
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Phone: 301-797-8279
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Houston, Texas 77042
Phone: 713-523-6700
?
mi
from
Houston, TX
Click here to add this to my saved trials
Joliet, Illinois 60435
Phone: 815-730-3098
?
mi
from
Joliet, IL
Click here to add this to my saved trials
Lafayette, Indiana
Phone: 765-446-5111
?
mi
from
Lafayette, IN
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Phone: 786-362-5763
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Phone: 786-615-0780
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Midlothian, Virginia 23114
Phone: 804-893-8611
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
Riverside, California 92501
Phone: 951-276-2760
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
Phone: 803-329-7772
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
Rockford, Illinois 61108
Phone: 815-227-2674
?
mi
from
Rockford, IL
Click here to add this to my saved trials
South Bend, Indiana 46628
Phone: 574-234-6485
?
mi
from
South Bend, IN
Click here to add this to my saved trials
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...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Staten Island, New York 10310
Principal Investigator: Mahmoud H Aly, MD
Phone: 718-818-2707
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Tampa, Florida 33612
Phone: 813-844-8712
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tupelo, Mississippi 38801
Phone: 662-377-4629
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Winter Haven, Florida 33880
Phone: 863-293-1191
?
mi
from
Winter Haven, FL
Click here to add this to my saved trials