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

Primary Purpose

Anemia, Iron-Deficiency, Kidney Failure, Chronic, Hemodialysis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium ferric gluconate,
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring iron deficiency anemia, ferritin, hemodialysis, sodium ferric gluconate, epoetin alfa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ferric gluconate

standard of care

Arm Description

Outcomes

Primary Outcome Measures

Change in hemoglobin and anemia medications

Secondary Outcome Measures

Change in various iron indices

Full Information

First Posted
September 13, 2005
Last Updated
December 8, 2015
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224081
Brief Title
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
Acronym
DRIVE
Official Title
Dialysis Patients' Response to IV Iron With Elevated Ferritin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency, Kidney Failure, Chronic, Hemodialysis
Keywords
iron deficiency anemia, ferritin, hemodialysis, sodium ferric gluconate, epoetin alfa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric gluconate
Arm Type
Experimental
Arm Title
standard of care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Sodium ferric gluconate,
Intervention Description
Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
Primary Outcome Measure Information:
Title
Change in hemoglobin and anemia medications
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in various iron indices
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel R. Rizkala, Pharm.D., MS
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Bakersfield
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Roswell
State/Province
Georgia
Country
United States
City
Waycross
State/Province
Georgia
Country
United States
City
Crestwood
State/Province
Illinois
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Kalamazoo
State/Province
Michigan
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Columbia
State/Province
Missouri
Country
United States
City
St Louis
State/Province
Missouri
Country
United States
City
North Brunswick
State/Province
New Jersey
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Minneola
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Youngstown
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17267740
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.
Results Reference
result
PubMed Identifier
17396118
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.
Results Reference
result
PubMed Identifier
18216316
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.
Results Reference
result
PubMed Identifier
19034302
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.
Results Reference
result

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

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