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

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

Sponsors

Lead Sponsor: American Regent, Inc.

Source 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.

Overall Status Completed
Start Date August 2009
Completion Date August 2011
Primary Completion Date July 2011
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 2561
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ferric Carboxymaltose (FCM)

Description: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg

Arm Group Label: Ferric Carboxymaltose (FCM)

Intervention Type: Drug

Intervention Name: Iron Sucrose (Venofer)

Description: 5 doses of 200 mg for a total cumulative dose of 1000 mg

Arm Group Label: Iron Sucrose (Venofer)

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Luitpold Pharmaceuticals, Inc.
Location Countries

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ferric Carboxymaltose (FCM)

Type: Experimental

Description: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg

Label: Iron Sucrose (Venofer)

Type: Active Comparator

Description: 5 doses of 200 mg for a total cumulative dose of 1000 mg

Acronym REPAIR-IDA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov