DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) (DRIVE)

December 8, 2015 updated by: Watson Pharmaceuticals

Dialysis Patients' Response to IV Iron With Elevated Ferritin

This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 4

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
    • California
      • Bakersfield, California, United States
      • Glendale, California, United States
      • Los Angeles, California, United States
      • Santa Rosa, California, United States
      • Torrance, California, United States
    • Florida
      • Lauderdale Lakes, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Roswell, Georgia, United States
      • Waycross, Georgia, United States
    • Illinois
      • Crestwood, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Kalamazoo, Michigan, United States
      • Royal Oak, Michigan, United States
    • Missouri
      • Columbia, Missouri, United States
      • St Louis, Missouri, United States
    • New Jersey
      • North Brunswick, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Minneola, New York, United States
      • New York, New York, United States
    • Ohio
      • Youngstown, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Knoxville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • West Virginia
      • Morgantown, West 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:

  • Chronic hemodialysis
  • Elevated serum ferritin with low to normal transferrin saturation (TSAT)
  • Moderate to severe anemia
  • Receiving epoetin alfa treatment

Exclusion Criteria:

  • Known sensitivity to Ferrlecit®
  • Medical conditions that would confound the efficacy evaluation
  • Recent blood transfusion

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
No Intervention: standard of care
Experimental: Ferric gluconate
Drug: Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin and anemia medications
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in various iron indices
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2004

Primary Completion (Actual)

May 1, 2006

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)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER0401

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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