Clinical trial NCT02817555: Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
Official title: A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Chronic Kidney Disease
Keywords: Anemia
Hemodialysis
Erythropoiesis Stimulating Agent
Cost
Lead sponsor: Eastern Health, Canada
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cost of Erythropoiesis Stimulating Agent
timeFrame: 12 months
Secondary outcomes:
measure: Hemoglobin
timeFrame: 12 months
measure: Ferritin
timeFrame: 12 months
measure: Transferrin Saturation (TSAT)
timeFrame: 12 months
measure: Iron Dose
timeFrame: 12 months
measure: Iron Cost
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Eastern Health, Canada
name: Andrea L Woodland, BScPharm,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Can J Kidney Health Dis. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. eCollection 2017.