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

Phase 4

Completed

Brief 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.

Detailed Description: Eligible hemodialysis patients who are currently receiving an erythropoiesis stimulating agent (ESA) who enrol and sign consent will be randomized on a 1:1 basis to either remain on epoetin alfa or switch to darbepoetin alfa as their anemia therapy. Patients will be dosed with the assigned drug using a study algorithm to maintain their hemoglobin (Hb) level within the currently recommended range (100-120 g/L). There will be an initial "run in" period of a minimum of six weeks to ensure the patient's hemoglobin is stable within the target range. The trial itself will run for a subsequent twelve months (active phase). Every effort will be made to ensure that Hb stays within the target range during the study period. The primary outcome will be the total cost of each ESA therapy over the twelve month active phase. Data including Hgb, iron indices and dosing, and clinical events will be obtained from electronic sources and from the attending physicians and/or the clinical pharmacist.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Epoetin alfa	Epoetin Alfa	Patients who are enrolled and randomized to the Epoetin arm will remain on their current dose and frequency. After the first hemoglobin (Hb) measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on epoetin for the required run-in phase followed by the 12 month active phase.
Darbepoetin alfa	Darbepoetin alfa	Patients who are enrolled and randomized to the Darbepoetin arm will have their epoetin discontinued at the end of the week preceding entry into the study and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin. Switching patients to darbepoetin will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded up or down to the nearest available pre-filled syringe dose available from the manufacturer. After the first Hb measurement the study algorithm will be used to guide anemia management. The subjects in this arm will remain on darbepoetin for the required run-in phase followed by the 12 month active phase.

Primary Outcome Measures

Name	Time	Method
Cost of Erythropoiesis Stimulating Agent	12 months	total cost over 12 months in Canadian dollars

Secondary Outcome Measures

Name	Time	Method
Iron Cost	12 months	total iron cost over 12 months in Canadian dollars
Ferritin	12 months	mean ferritin (ug/L) over 12 months
Hemoglobin	12 months	median hemoglobin (g/L) over 12 months
Transferrin Saturation (TSAT)	12 months	median TSAT (%) over 12 months
Iron Dose	12 months	median weekly iron dose (mg) over 12 months