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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224081
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 10, 2015
Information provided by (Responsible Party):
Watson Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Kidney Failure, Chronic Hemodialysis Drug: Sodium ferric gluconate, Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dialysis Patients' Response to IV Iron With Elevated Ferritin
Study Start Date : September 2004
Actual Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis Iron

Arm Intervention/treatment
Experimental: Ferric gluconate Drug: Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions

No Intervention: standard of care

Primary Outcome Measures :
  1. Change in hemoglobin and anemia medications [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in various iron indices [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00224081

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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
United States, Florida
Lauderdale Lakes, Florida, United States
Tampa, Florida, United States
United States, Georgia
Roswell, Georgia, United States
Waycross, Georgia, United States
United States, Illinois
Crestwood, Illinois, United States
United States, Kansas
Wichita, Kansas, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Kalamazoo, Michigan, United States
Royal Oak, Michigan, United States
United States, Missouri
Columbia, Missouri, United States
St Louis, Missouri, United States
United States, New Jersey
North Brunswick, New Jersey, United States
United States, New York
Brooklyn, New York, United States
Minneola, New York, United States
New York, New York, United States
United States, Ohio
Youngstown, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, West Virginia
Morgantown, West Virginia, United States
Sponsors and Collaborators
Watson Pharmaceuticals
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Study Director: Adel R. Rizkala, Pharm.D., MS Watson Laboratories, Inc.

Publications of Results:
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Responsible Party: Watson Pharmaceuticals Identifier: NCT00224081    
Other Study ID Numbers: FER0401
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by Watson Pharmaceuticals:
iron deficiency anemia
sodium ferric gluconate
epoetin alfa
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Ferric gluconate
Ferric Compounds