2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

May 17, 2013 updated by: Watson Pharmaceuticals

A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 2
  • 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

  • Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
      • Kelowna, Canada
      • Kitchener, Canada
      • London, Canada
      • Scarborough, Canada
      • Toronto, Canada
  • Croatia
      • Zagreb, Croatia
  • India
      • Bangalore, India
      • Chandigarh, India
      • Chennai, India
      • Hyderabad, India
      • Lucknow, India
      • Mahim, India
      • New Delhi, India
  • Mexico
      • Col. Toriello Guerra, Mexico
      • Durango, Mexico
      • Mexico City, Mexico
      • Monterrey, Mexico
      • Tlalpan, Mexico
      • Zapopan, Mexico
  • Poland
      • Osijek, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
    • California
      • Los Angeles, California, United States
      • Torrance, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Illinois
      • Evanston, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Winston-salem, North Carolina, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Texas
      • Dallas, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, at least 18 years of age.
  • Received maintenance peritoneal dialysis therapy for at least 4 weeks.
  • Was expected to remain on peritoneal dialysis therapy for duration of study.
  • Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
  • Signed patient informed consent.

Exclusion Criteria:

  • Had a predetermined serum levels of Ferritin and TSAT
  • Pregnant or lactating.
  • Had a serious concomitant medical disorder incompatible with participation in the study.
  • Had a known hypersensitivity to Ferrlecit or any of its components.
  • Unable to cooperate or comply with the protocol.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sodium ferric gluconate complex 125 mg
125 mg sodium ferric gluconate weekly x 8 weeks
Drug: Sodium Ferric Gluconate Complex
125 mg weekly x 8 weeks
Other Names:
  • Ferrlecit
Drug: Sodium Ferric Gluconate Complex
250 mg weekly x 4
Other Names:
  • Ferrlecit
EXPERIMENTAL: Sodium ferric gluconate complex 250 mg
250 mg sodium ferric gluconate complex weekly x 4 weeks
Drug: Sodium Ferric Gluconate Complex
125 mg weekly x 8 weeks
Other Names:
  • Ferrlecit
Drug: Sodium Ferric Gluconate Complex
250 mg weekly x 4
Other Names:
  • Ferrlecit
ACTIVE_COMPARATOR: Oral iron
325 mg ferrous sulfate three times daily x 8 weeks
Drug: Oral Iron
325 mg ferrous sulfate orally three times daily x 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: Baseline to 5 weeks and 9 weeks
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Baseline to 5 weeks and 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hematocrit (Hct)
Time Frame: Baseline to 5 weeks and 9 weeks
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Baseline to 5 weeks and 9 weeks
Change From Baseline in Transferrin Saturation (TSAT).
Time Frame: Baseline to 5 weeks and 9 weeks
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Baseline to 5 weeks and 9 weeks
Change From Baseline in Serum Ferritin.
Time Frame: Baseline to 5 weeks and 9 weeks
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Baseline to 5 weeks and 9 weeks
Responders by Treatment Group
Time Frame: Baseline to 5 weeks and 9 weeks
Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.
Baseline to 5 weeks and 9 weeks

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Chair: Gary Hoel, RPh, PhD, Watson Pharmaceuticals

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

December 1, 2003

Primary Completion (ACTUAL)

November 1, 2004

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR03001

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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