Clinical trial NCT00224081: DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
Official title: Dialysis Patients' Response to IV Iron With Elevated Ferritin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia, Iron-Deficiency
Kidney Failure, Chronic
Hemodialysis
Keywords: iron deficiency anemia
ferritin
hemodialysis
sodium ferric gluconate
epoetin alfa
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in hemoglobin and anemia medications
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in various iron indices
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Torrance
country: United States
state: California
city: Lauderdale Lakes
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Roswell
country: United States
state: Georgia
city: Waycross
country: United States
state: Georgia
city: Crestwood
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: North Brunswick
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Minneola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Youngstown
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Watson Laboratories, Inc.
name: Adel R. Rizkala, Pharm.D., MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.