At a glance
ClinicalIndex Comparison Record- ✓Age 19 years or older
- ✓Receiving in-center hemodialysis two or more times per week
- ✓Anemia requiring erythropoiesis stimulating agent (ESA) therapy OR hemoglobin <100 g/L without other causes of anemia
- ✓Able to provide informed consent
- ✕Acute kidney injury likely to resolve
- ✕Plans to change dialysis modality (peritoneal dialysis, home hemodialysis) or planned living-donor transplant
- ✕Expected lifespan <6 months from non-CKD medical conditions
- ✕Current hematologic condition causing anemia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
In Brief
A Phase 4 clinical trial evaluating Epoetin Alfa and Darbepoetin alfa for Anemia and Chronic Kidney Disease. Completed, enrolled 50 participants.
Detailed Summary
The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.
Study Details
Timeline
Interventions
The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study. All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe. It is not anticipated that a subject will require a dose of epoetin \> 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal. Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate.
The investigator will adjust darbepoetin doses as per the study algorithm during the run-in (every two weeks) and active phases(every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study. All darbepoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe. It is not anticipated that a subject will require a dose of darbepoetin \>150µg weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal. Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate.