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

Andrea L Woodland

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Anemia

Treatments: Drug: Epoetin Alfa; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT02817555

HIC10.104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Epoetin alfa

Active Comparator group

Description:

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.

Treatment:

Drug: Epoetin Alfa

Darbepoetin alfa

Active Comparator group

Description:

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.

Treatment:

Drug: Darbepoetin alfa