Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–85 year

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

Male or Female 18 to 85 years of age
NDD-CKD Patients
TSAT </= 25%
Hgb </= 11.5
Ferritin </= 300
HD-CKD Patients
TSAT </= 30%
Hgb </= 12
Ferritin </= 500

Exclusion criteria

Previous participation in a FCM trial
Known Hypersensitivity to FCM
History of anemia other that anemia due to chronic renal failure
Current history of GI bleeding
Received IV Iron within the last 30 Days
Anticipated need for surgery
Malignancy history
AST or ALT greater than 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

Drug

Standard Medical Care (SMC)

Drug

Primary outcomes

Incidence of Treatment-emergent Serious Adverse Events (SAE's)

Time frame: from Day 0 through 30 days after the last dose of study drug

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 IV Ferric Carboxymaltose (FCM) vs Standard Medical Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 24, 2007
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.

Published trials that share one or more normalized conditions with this study.

Completed