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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Erythropoiesis Stimulating Agent | total cost over 12 months in Canadian dollars | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | median hemoglobin (g/L) over 12 months | 12 months |
| Ferritin | mean ferritin (ug/L) over 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea L Woodland, BScPharm,MSc | Eastern Health, Canada | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | 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. | |
| 28717516 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epoetin Alfa | Patients who are enrolled and randomized to the Epoetin arm will remain on their pre-enrollment 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. 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. |
| FG001 | Darbepoetin Alfa | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epoetin Alfa | 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. The subjects will remain on epoetin for the required run-in phase followed by the 12 month active phase. The investigator will adjust epoetin doses as per the study algorithm during the run-in and active phases. 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. Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cost of Erythropoiesis Stimulating Agent | total cost over 12 months in Canadian dollars | Posted | Median | Inter-Quartile Range | dollars Canadian | 12 months |
|
Run in phase and 12 month study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epoetin Alfa | Patients who are enrolled and randomized to the Epoetin arm will remain on their pre-enrollment 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. 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. |
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Did not recruit planned number, incomplete follow up in 8 subjects, cannot be generalized to centres without pre-defined dosing algorithms, non-dialysis CKD, or sc administration of ESAs. Trial looked at drug acquisition cost only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Woodland | Eastern Health | 7097778146 | andrea.woodland@easternhealth.ca |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
|
| 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. |
|
|
| Transferrin Saturation (TSAT) | median TSAT (%) over 12 months | 12 months |
| Iron Dose | median weekly iron dose (mg) over 12 months | 12 months |
| Iron Cost | total iron cost over 12 months in Canadian dollars | 12 months |
| transplant |
|
| changed to Peritoneal Dialysis |
|
| BG001 | Darbepoetin Alfa | Patients who are randomized to the Darbepoetin arm will have their epoetin and will switch to darbepoetin on the date that they would normally be receiving their next dose of epoetin. Switching patients will be done using the conversion ratio of 200 units of epoetin to 1 μg of darbepoetin as used per week, rounded to the nearest pre-filled syringe available from the manufacturer. After the first Hb measurement the study algorithm will be used. The investigator will adjust darbepoetin doses as per the study algorithm during the run-in and active phases. 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. 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. Intravenous iron will be given as per the study algorithm, sodium ferric gluconate. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Darbepoetin Alfa | 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. 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. |
|
|
| Secondary | Hemoglobin | median hemoglobin (g/L) over 12 months | Posted | Median | Inter-Quartile Range | g/L | 12 months |
|
|
|
| Secondary | Ferritin | mean ferritin (ug/L) over 12 months | Posted | Mean | Standard Deviation | ug/L | 12 months |
|
|
|
| Secondary | Transferrin Saturation (TSAT) | median TSAT (%) over 12 months | Posted | Median | Inter-Quartile Range | percentage saturation | 12 months |
|
|
|
| Secondary | Iron Dose | median weekly iron dose (mg) over 12 months | Posted | Median | Inter-Quartile Range | mg/week | 12 months |
|
|
|
| Secondary | Iron Cost | total iron cost over 12 months in Canadian dollars | Posted | Median | Inter-Quartile Range | canadian dollars | 12 months |
|
|
|
| 1 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Darbepoetin Alfa | 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. 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. | 3 | 26 | 0 | 26 | 0 | 26 |
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |