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

Sponsor

Watson Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00224081

Collaborator

(none)

134

Enrollment

Locations

Arms

4.6

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia, Iron-Deficiency Kidney Failure, Chronic Hemodialysis	Drug: Sodium ferric gluconate,	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dialysis Patients' Response to IV Iron With Elevated Ferritin

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferric gluconate	Drug: Sodium ferric gluconate, Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions
No Intervention: standard of care

Arm

Intervention/Treatment

Experimental: Ferric gluconate

Drug: Sodium ferric gluconate,

Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions

No Intervention: standard of care

Outcome Measures

Primary Outcome Measures

Change in hemoglobin and anemia medications [6 weeks]

Secondary Outcome Measures

Change in various iron indices [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Bakersfield	California	United States
2	Glendale	California	United States
3	Los Angeles	California	United States
4	Santa Rosa	California	United States
5	Torrance	California	United States
6	Lauderdale Lakes	Florida	United States
7	Tampa	Florida	United States
8	Roswell	Georgia	United States
9	Waycross	Georgia	United States
10	Crestwood	Illinois	United States
11	Wichita	Kansas	United States
12	Shreveport	Louisiana	United States
13	Boston	Massachusetts	United States
14	Kalamazoo	Michigan	United States
15	Royal Oak	Michigan	United States
16	Columbia	Missouri	United States
17	St Louis	Missouri	United States
18	North Brunswick	New Jersey	United States
19	Brooklyn	New York	United States
20	Minneola	New York	United States
21	New York	New York	United States
22	Youngstown	Ohio	United States
23	Philadelphia	Pennsylvania	United States
24	Chattanooga	Tennessee	United States
25	Knoxville	Tennessee	United States
26	Arlington	Texas	United States
27	Houston	Texas	United States
28	San Antonio	Texas	United States
29	Morgantown	West Virginia	United States