Skip to main content
OpenTrials
Completed

NCT Number: NCT02817555

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin alfa

Drug

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.

Other names: Eprex

darbepoetin alfa

Drug

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.

Other names: Aranesp

Primary outcomes

  1. Cost of Erythropoiesis Stimulating Agent

    Time frame: 12 months

    total cost over 12 months in Canadian dollars

Secondary outcomes

  1. Hemoglobin

    Time frame: 12 months

    median hemoglobin (g/L) over 12 months

  2. Ferritin

    Time frame: 12 months

    mean ferritin (ug/L) over 12 months

  3. Transferrin Saturation (TSAT)

    Time frame: 12 months

    median TSAT (%) over 12 months

  4. Iron Dose

    Time frame: 12 months

    median weekly iron dose (mg) over 12 months

  5. Iron Cost

    Time frame: 12 months

    total iron cost over 12 months in Canadian dollars

Sponsors and collaborators

Lead sponsor

Andrea L Woodland

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2016
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.