NCT00982007

Brief Summary

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
997

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 18, 2013

Completed
Last Updated

February 20, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

September 21, 2009

Results QC Date

August 14, 2013

Last Update Submit

January 22, 2018

Conditions

Iron Deficiency Anemia

Keywords

IDA

Outcome Measures

Primary Outcomes (1)

  • Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.

    Day 35

Study Arms (4)

Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)

EXPERIMENTAL

Intravenous (IV) iron

Drug: Ferric Carboxymaltose (FCM)

Cohort 1 (Group B) - Ferrous Sulfate

ACTIVE COMPARATOR

Oral iron - Ferrous Sulfate tablets

Drug: Ferrous Sulfate Tablets

Cohort 2 (Group D) - IV Iron (standard of care)

ACTIVE COMPARATOR

Other IV iron

Drug: IV Iron (standard of care)

Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)

EXPERIMENTAL

Intravenous (IV) iron

Drug: Ferric Carboxymaltose (FCM)

Interventions

Ferric Carboxymaltose (FCM)DRUG

A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Ferrous Sulfate TabletsDRUG

325 mg Ferrous Sulfate tablets taken orally three times a day

Cohort 1 (Group B) - Ferrous Sulfate
IV Iron (standard of care)DRUG

IV standard of care (other IV iron) per the Investigator's discretion

Cohort 2 (Group D) - IV Iron (standard of care)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects ≥ to 18 years of age and able to give informed consent.
  • Diagnosis of Iron Deficiency Anemia (IDA).
  • Hemoglobin (Hgb) ≤ to 11 g/dL.
  • Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
  • Must demonstrate an unsatisfactory response or intolerance to oral iron.

You may not qualify if:

  • Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
  • Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
  • Requires dialysis for treatment of chronic kidney disease.
  • No evidence of iron deficiency.
  • Any non-viral infection.
  • AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
  • 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.
  • Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
  • 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 sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltoseIron-Dextran Complexferryl ironStandard of Care

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydratesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Mark A. Falone
Organization
Luitpold Pharmaceuticals, Inc.
mfalone@luitpold.com
610-650-4200

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2011

Study Completion

August 1, 2011

Last Updated

February 20, 2018

Results First Posted

October 18, 2013

Record last verified: 2018-01

Locations

US(1)