DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
Phase 4
Completed
- Conditions
- Anemia, Iron-DeficiencyKidney Failure, ChronicHemodialysis
- Interventions
- Drug: Sodium ferric gluconate,
- Registration Number
- NCT00224081
- Lead Sponsor
- Watson Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ferric gluconate Sodium ferric gluconate, -
- Primary Outcome Measures
Name Time Method Change in hemoglobin and anemia medications 6 weeks
- Secondary Outcome Measures
Name Time Method Change in various iron indices 6 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does sodium ferric gluconate modulate iron metabolism in hemodialysis patients with elevated serum ferritin and low transferrin saturation?
What is the comparative efficacy of IV iron versus oral iron in anemic hemodialysis patients with high ferritin levels?
Which biomarkers in NCT00224081 predict response to IV iron in epoetin-treated hemodialysis patients with high ferritin?
What adverse events are associated with IV iron in NCT00224081 and how are they managed in chronic kidney disease populations?
How does sodium ferric gluconate compare to iron sucrose or ferric carboxymaltose in anemia management for hemodialysis patients with iron-restricted erythropoiesis?