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

American Regent

Status and phase: Completed; Phase 3

Conditions: Cancer and Chemotherapy Related Anemia

Treatments: Drug: Injectafer; Other: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453334

1VIT14039

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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244 participants in 2 patient groups, including a placebo group

Injectafer

Experimental group

Description:

2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.

Treatment:

Drug: Injectafer

Normal Saline

Placebo Comparator group

Description:

Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.

Treatment:

Other: Normal Saline