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

This study has been completed.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals Identifier:
First received: October 22, 2007
Last updated: May 11, 2015
Last verified: May 2015
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure

Condition Intervention Phase
Anemia Drug: Ferric Carboxymaltose Drug: Standard Medical Care (SMC) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of Treatment-emergent Serious Adverse Events (SAE's) [ Time Frame: from Day 0 through 30 days after the last dose of study drug ]

Enrollment: 513
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM)
Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
Drug: Ferric Carboxymaltose
Active Comparator: Standard Medical Care (SMC)
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
Drug: Standard Medical Care (SMC)


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00548691

United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00548691     History of Changes
Other Study ID Numbers: 1VIT07018
Study First Received: October 22, 2007
Results First Received: September 16, 2013
Last Updated: May 11, 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics processed this record on August 18, 2017