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Completed

NCT Number: NCT00703937

Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects ≥ 18 years of age and able to give informed consent
  • Iron deficiency is the primary etiology of anemia
  • Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL
  • Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

Exclusion criteria

  • Previous participation in a FCM trial
  • Known hypersensitivity reaction to FCM
  • Requires dialysis for treatment of chronic kidney disease
  • Current anemia not attributed to iron deficiency
  • Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
  • Anticipated need for surgery
  • AST or ALT greater than 1.5 times the upper limit of normal
  • Received an investigational drug within 30 days of screening
  • Pregnant or sexually-active females who are not willing to use an effective form of birth control

Treatment and study plan

Ferric Carboxymaltose (FCM)

Drug

Standard Medical Care (SMC) for the treatment of IDA

Drug

Primary outcomes

  1. Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC

    Time frame: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer

    Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

A Multi-center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Jun 24, 2008
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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