Back to resultsCost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
Primary Purpose
Anemia, Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Epoetin Alfa
Darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, Hemodialysis, Erythropoiesis Stimulating Agent, Cost
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epoetin alfa
Darbepoetin alfa
Arm 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.
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.
Outcomes
Primary Outcome Measures
Cost of Erythropoiesis Stimulating Agent
total cost over 12 months in Canadian dollars
Secondary Outcome Measures
Hemoglobin
median hemoglobin (g/L) over 12 months
Ferritin
mean ferritin (ug/L) over 12 months
Transferrin Saturation (TSAT)
median TSAT (%) over 12 months
Iron Dose
median weekly iron dose (mg) over 12 months
Iron Cost
total iron cost over 12 months in Canadian dollars
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02817555
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrea L Woodland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease
Keywords
Anemia, Hemodialysis, Erythropoiesis Stimulating Agent, Cost
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epoetin alfa
Arm Type
Active Comparator
Arm 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.
Arm Title
Darbepoetin alfa
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Other Intervention Name(s)
Eprex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Other Intervention Name(s)
Aranesp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost of Erythropoiesis Stimulating Agent
Description
total cost over 12 months in Canadian dollars
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
median hemoglobin (g/L) over 12 months
Time Frame
12 months
Title
Ferritin
Description
mean ferritin (ug/L) over 12 months
Time Frame
12 months
Title
Transferrin Saturation (TSAT)
Description
median TSAT (%) over 12 months
Time Frame
12 months
Title
Iron Dose
Description
median weekly iron dose (mg) over 12 months
Time Frame
12 months
Title
Iron Cost
Description
total iron cost over 12 months in Canadian dollars
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L Woodland, BScPharm,MSc
Organizational Affiliation
Eastern Health, Canada
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28717516
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.
Results Reference
derived
Learn more about this trial
Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
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