DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
NCT ID: NCT00224081
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
134 participants
INTERVENTIONAL
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ferric gluconate
Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
standard of care
No interventions assigned to this group
Interventions
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Sodium ferric gluconate,
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
Eligibility Criteria
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Inclusion Criteria
* Elevated serum ferritin with low to normal transferrin saturation (TSAT)
* Moderate to severe anemia
* Receiving epoetin alfa treatment
Exclusion Criteria
* Medical conditions that would confound the efficacy evaluation
* Recent blood transfusion
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Adel R. Rizkala, Pharm.D., MS
Role: STUDY_DIRECTOR
Watson Laboratories, Inc.
Locations
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Bakersfield, California, United States
Glendale, California, United States
Los Angeles, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Lauderdale Lakes, Florida, United States
Tampa, Florida, United States
Roswell, Georgia, United States
Waycross, Georgia, United States
Crestwood, Illinois, United States
Wichita, Kansas, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Kalamazoo, Michigan, United States
Royal Oak, Michigan, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
North Brunswick, New Jersey, United States
Brooklyn, New York, United States
Minneola, New York, United States
New York, New York, United States
Youngstown, Ohio, United States
Philadelphia, Pennsylvania, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Morgantown, West Virginia, United States
Countries
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References
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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.
Singh 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.
Kapoian 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.
Pizzi 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.
Other Identifiers
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FER0401
Identifier Type: -
Identifier Source: org_study_id