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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224081
First received: September 13, 2005
Last updated: November 29, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Anemia, Iron-Deficiency
Kidney Failure, Chronic
Hemodialysis
 Drug: Sodium ferric gluconate,
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dialysis Patients' Response to IV Iron With Elevated Ferritin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Change in hemoglobin and anemia medications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in various iron indices [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: September 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric gluconate Drug: Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
No Intervention: standard of care Drug: Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224081

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

Publications:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224081     History of Changes
Other Study ID Numbers: FER0401
Study First Received: September 13, 2005
Last Updated: November 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Watson Pharmaceuticals:
iron deficiency anemia
ferritin
hemodialysis
sodium ferric gluconate
epoetin alfa

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

ClinicalTrials.gov processed this record on May 22, 2013