Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrea L Woodland
• Treatments: Darbepoetin alfa; Epoetin Alfa; Ferric gluconate

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