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

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ClinicalTrials.gov Identifier: NCT00548691
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : May 13, 2015
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Anemia Drug: Ferric Carboxymaltose Drug: Standard Medical Care (SMC) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548691


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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548691     History of Changes
Other Study ID Numbers: 1VIT07018
First Posted: October 24, 2007    Key Record Dates
Results First Posted: May 13, 2015
Last Update Posted: February 20, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics