Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Epoetin Alfa; Darbepoetin alfa
Intervention description: 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 This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.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 This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.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.
Intervention MeSH terms: Epoetin Alfa; Darbepoetin alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Anemia; Hemodialysis; Erythropoiesis Stimulating Agent; Cost

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age ≥19 years

          -  receiving in-center hemodialysis two or more times weekly

          -  anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a
             hemoglobin(Hb)<100g/L in the absence of other causes of anemia

          -  if female, must be using an approved method of contraception or judged unable to
             become pregnant

          -  able to give informed consent

        Exclusion Criteria:

          -  acute kidney injury likely to resolve

          -  plans to change to peritoneal dialysis or home hemodialysis, or planned transplant
             from a living donor

          -  expected lifespan of less than six months due to a medical condition other than
             chronic kidney disease

          -  current hematologic condition that may cause anemia

          -  use of medications known to cause anemia

          -  use of any investigational drug or androgen within 90 days of screening

          -  significant bleeding within 30 days of screening

          -  red blood cell transfusion(s) within 30 days of screening

          -  documented or suspected pure red cell aplasia (PRCA)

          -  current iron deficiency

          -  documented allergy or intolerance to intravenous sodium ferric gluconate

          -  known or probable ESA resistance

          -  uncontrolled hypertension

          -  an intention to relocate to a different dialysis center in the near future