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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.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE September 2004
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
Change in hemoglobin and anemia medications [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Change in hemoglobin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
Change in various iron indices [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Change in various iron indices
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
Official Title  ICMJE Dialysis Patients' Response to IV Iron With Elevated Ferritin
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia, Iron-Deficiency
  • Kidney Failure, Chronic
  • Hemodialysis
Intervention  ICMJE Drug: Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
Study Arms  ICMJE
  • Experimental: Ferric gluconate
    Intervention: Drug: Sodium ferric gluconate,
  • No Intervention: standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2011)
134
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
150
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224081
Other Study ID Numbers  ICMJE FER0401
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Watson Pharmaceuticals
Study Sponsor  ICMJE Watson Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Adel R. Rizkala, Pharm.D., MS Watson Laboratories, Inc.
PRS Account Watson Pharmaceuticals
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP