Tampa, Florida 33606

  • Cancer and Chemotherapy Related Anemia

Purpose:

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.


Study summary:

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).


Criteria:

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).


Study is Available At:


Original ID:

1VIT14039


NCT ID:

NCT02453334


Secondary ID:


Study Acronym:

IRON CLAD


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Luitpold Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

244


Enrollment Type:

Actual


Study Dates

Start Date:July 2015
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:January 2018
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 21, 2018
First Received Date:May 21, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percentage of patients with a decrease in Hgb ≥ 0.5 g/dL from Week 3 to Week 18
Time Frame:Week 3 to Week 18
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Injectafer
Arm Name:Injectafer
Other Name:ferric carboxymaltose injection
Intervention Type:Other
Name:Normal Saline
Arm Name:Normal Saline

Study Arms

Study Arm Type:Experimental
Arm Name:Injectafer
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.
Study Arm Type:Placebo Comparator
Arm Name:Normal Saline
Description:Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Luitpold Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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