DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
DRIVE
Dialysis Patients' Response to IV Iron With Elevated Ferritin
1 other identifier
interventional
134
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedDecember 10, 2015
December 1, 2015
1.7 years
September 13, 2005
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in hemoglobin and anemia medications
6 weeks
Secondary Outcomes (1)
Change in various iron indices
6 weeks
Study Arms (2)
Ferric gluconate
EXPERIMENTALstandard of care
NO INTERVENTIONInterventions
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
Eligibility Criteria
You may qualify if:
- Chronic hemodialysis
- Elevated serum ferritin with low to normal transferrin saturation (TSAT)
- Moderate to severe anemia
- Receiving epoetin alfa treatment
You may not qualify if:
- Known sensitivity to Ferrlecit®
- Medical conditions that would confound the efficacy evaluation
- Recent blood transfusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Santa Rosa, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Lauderdale Lakes, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Roswell, Georgia, United States
Unknown Facility
Waycross, Georgia, United States
Unknown Facility
Crestwood, Illinois, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Columbia, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
North Brunswick, New Jersey, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Minneola, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Youngstown, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Chattanooga, Tennessee, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Morgantown, West Virginia, United States
Related Publications (4)
Coyne DW, Kapoian T, Suki W, Singh AK, Moran JE, Dahl NV, Rizkala AR; DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. J Am Soc Nephrol. 2007 Mar;18(3):975-84. doi: 10.1681/ASN.2006091034. Epub 2007 Jan 31.
PMID: 17267740RESULTSingh AK, Coyne DW, Shapiro W, Rizkala AR; DRIVE Study Group. Predictors of the response to treatment in anemic hemodialysis patients with high serum ferritin and low transferrin saturation. Kidney Int. 2007 Jun;71(11):1163-71. doi: 10.1038/sj.ki.5002223. Epub 2007 Mar 28.
PMID: 17396118RESULTKapoian T, O'Mara NB, Singh AK, Moran J, Rizkala AR, Geronemus R, Kopelman RC, Dahl NV, Coyne DW. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008 Feb;19(2):372-9. doi: 10.1681/ASN.2007050606. Epub 2008 Jan 23.
PMID: 18216316RESULTPizzi LT, Bunz TJ, Coyne DW, Goldfarb DS, Singh AK. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int. 2008 Dec;74(12):1588-95. doi: 10.1038/ki.2008.489. Epub 2008 Oct 1.
PMID: 19034302RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adel R. Rizkala, Pharm.D., MS
Watson Laboratories, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
September 1, 2004
Primary Completion
May 1, 2006
Last Updated
December 10, 2015
Record last verified: 2015-12