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

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ClinicalTrials.gov Identifier: NCT00224081
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 10, 2015
Sponsor:
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

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 Iron
U.S. FDA Resources

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00224081


  Show 29 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Adel R. Rizkala, Pharm.D., MS Watson Laboratories, Inc.

Publications of Results:
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224081     History of Changes
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
ferritin
hemodialysis
sodium ferric gluconate
epoetin alfa

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Renal Insufficiency
Kidney Failure, Chronic
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Ferric gluconate
Ferric Compounds
Hematinics