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

Dialysis Patients' Response to IV Iron With Elevated Ferritin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00224081

Acronym

DRIVE

Enrollment

134

Registered

2005-09-22

Start date

2004-09-30

Completion date

Unknown

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

iron deficiency anemia, ferritin, hemodialysis, sodium ferric gluconate, epoetin alfa

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.

Interventions

DRUGSodium ferric gluconate,

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin and anemia medications	6 weeks

Secondary

Measure	Time frame
Change in various iron indices	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026