AnemiaPhase 4NCT02817555
Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients
A Phase 4 study testing Epoetin Alfa and Darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Andrea L Woodland.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia, Chronic Kidney Disease
- What is being tested?
- Epoetin Alfa and Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
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.
Read the 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.
- Conditions
- Anemia, Chronic Kidney Disease
- Being tested
- Epoetin Alfa, Darbepoetin alfa
- Keywords
- Anemia, Hemodialysis, Erythropoiesis Stimulating Agent, Cost
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin AlfaDrug
Also called Eprex
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 alfaDrug
Also called Aranesp
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.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alfa | Active comparator | 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. Receives: Drug: Epoetin Alfa |
| Darbepoetin alfa | Active comparator | 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. Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of Erythropoiesis Stimulating Agent
total cost over 12 months in Canadian dollars
Measured: 12 months
Secondary outcomes (5)
Hemoglobin
median hemoglobin (g/L) over 12 months
Measured: 12 months
Ferritin
mean ferritin (ug/L) over 12 months
Measured: 12 months
Transferrin Saturation (TSAT)
median TSAT (%) over 12 months
Measured: 12 months
Iron Dose
median weekly iron dose (mg) over 12 months
Measured: 12 months
Iron Cost
total iron cost over 12 months in Canadian dollars
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startSep 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea L Woodland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea L Woodland, Eastern Health, Canada
- Investigators
- Andrea L Woodland, BScPharm,MSc, Principal investigator, Eastern Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817555
- Sponsor's protocol ID
- HIC10.104
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2016
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280Woodland 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.
PubMed 28717516
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
- ClinicalTrials.gov ID
- NCT02817555
- Acronym / sponsor ID
- HIC10.104
- Conditions
- Anemia, Chronic Kidney Disease
- Keywords
- Anemia, Hemodialysis, Erythropoiesis Stimulating Agent, Cost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Andrea L WoodlandUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Posted 10 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epoetin alfa | Active comparator | Drug: Epoetin AlfaPatients 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. |
| Darbepoetin alfa | Active comparator | Drug: Darbepoetin alfaPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin AlfaAlso: EprexThe 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. | Drug | Epoetin alfa |
| Darbepoetin alfaAlso: AranespThe 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. | Drug | Darbepoetin alfa |
Primary outcome
Cost of Erythropoiesis Stimulating Agent
Time frame: 12 months
total cost over 12 months in Canadian dollars
5 secondary outcomes
Hemoglobin
Time frame: 12 months
Ferritin
Time frame: 12 months
Transferrin Saturation (TSAT)
Time frame: 12 months
Iron Dose
Time frame: 12 months
Iron Cost
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- Derived from this study: PubMed 28717516Woodland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea L Woodland, BScPharm,MSc principal investigator
Eastern Health, Canada
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin Alfa and Darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Andrea L Woodland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of Erythropoiesis Stimulating Agent (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817555, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.