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

Anemia Clinical Trial

Official title:

A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817555
• Other study ID #: HIC10.104
• Status: Completed
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2019
• Source: Eastern Health, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Epoetin Alfa
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.
• Darbepoetin alfa
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Andrea L Woodland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of Erythropoiesis Stimulating Agent	total cost over 12 months in Canadian dollars	12 months
Secondary	Hemoglobin	median hemoglobin (g/L) over 12 months	12 months
Secondary	Ferritin	mean ferritin (ug/L) over 12 months	12 months
Secondary	Transferrin Saturation (TSAT)	median TSAT (%) over 12 months	12 months
Secondary	Iron Dose	median weekly iron dose (mg) over 12 months	12 months
Secondary	Iron Cost	total iron cost over 12 months in Canadian dollars	12 months