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

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00548691
First received: October 22, 2007
Last updated: June 5, 2009
Last verified: June 2009
  Purpose

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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxy Maltose (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:
  • Safety and Tolerability [ Time Frame: 30 days ]

Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548691

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

No publications provided

ClinicalTrials.gov Identifier: NCT00548691     History of Changes
Other Study ID Numbers: 1VIT07018
Study First Received: October 22, 2007
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014