Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

Phase 3

Completed

• Conditions: Iron Deficiency Anemia; Impaired Renal Function
• Interventions: Drug: Ferric Carboxymaltose (FCM); Drug: Iron Sucrose (Venofer)

• Registration Number: NCT00981045
• Lead Sponsor: American Regent, Inc.

Brief Summary

The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Results First Submitted: 2013-08-14
• Results First Submitted QC: 2013-08-14
• Results First Posted: 2013-10-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2561

Inclusion Criteria

• Male or female subjects > or = to 18 years of age.
• Chronically impaired renal function.
• Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
• Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
• If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria

• Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
• Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
• Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
• No evidence of iron deficiency.
• Any non-viral infection.
• AST or ALT at screening 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 disorder 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 female subjects who are not willing to use an acceptable form of contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose (FCM)	2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Iron Sucrose (Venofer)	Iron Sucrose (Venofer)	5 doses of 200 mg for a total cumulative dose of 1000 mg

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.	Day 56
Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.	Day 120	The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.

Trial Locations

Locations (1)

Luitpold Pharmaceuticals, Inc.; 🇺🇸 Norristown, Pennsylvania, United States