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

January 22, 2018 updated by: American Regent, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

513

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19403
        • Luitpold Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 24, 2007

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VIT07018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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