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

Watson Pharmaceuticals134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Anemia, Iron-Deficiency Kidney Failure, Chronic Hemodialysis

Interventions

Sodium ferric gluconate,DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Unnamed facility

Bakersfield, California, United States

Outcomes

Primary Outcomes

Change in hemoglobin and anemia medications

Time frame: 6 weeks

Secondary Outcomes

Change in various iron indices

Time frame: 6 weeks

Data from ClinicalTrials.gov

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