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 (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00548691
First received: October 22, 2007
Last updated: May 11, 2015
Last verified: May 2015
  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
Drug: Standard Medical Care (SMC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: Yes ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2015