Trial Outcomes & Findings for Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients (NCT NCT02817555)

NCT ID: NCT02817555

Last Updated: 2019-09-10

Results Overview

total cost over 12 months in Canadian dollars

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-09-10

Participant Flow

Participant milestones

Measure	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 This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.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.	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 This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.
Overall Study STARTED	24	26
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	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.	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.
Overall Study Death	1	3
Overall Study moved away	1	0
Overall Study transplant	1	1
Overall Study changed to Peritoneal Dialysis	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Epoetin Alfa n=24 Participants 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.	Darbepoetin Alfa n=26 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 13.3 • n=5 Participants	61 years STANDARD_DEVIATION 15.1 • n=7 Participants	60.49 years STANDARD_DEVIATION 13.98 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Canada	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

total cost over 12 months in Canadian dollars

Outcome measures

Measure	Epoetin Alfa n=24 Participants 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. 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	Darbepoetin Alfa n=26 Participants 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.
Cost of Erythropoiesis Stimulating Agent	4178.70 dollars Canadian Interval 2416.37 to 5955.12	2302.92 dollars Canadian Interval 1177.86 to 4218.93

SECONDARY outcome

Timeframe: 12 months

median hemoglobin (g/L) over 12 months

Outcome measures

Measure	Epoetin Alfa n=24 Participants 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. 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	Darbepoetin Alfa n=26 Participants 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.
Hemoglobin	108 g/L Interval 106.0 to 112.7	109.8 g/L Interval 105.9 to 116.1

SECONDARY outcome

Timeframe: 12 months

mean ferritin (ug/L) over 12 months

Outcome measures

Measure	Epoetin Alfa n=24 Participants 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. 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	Darbepoetin Alfa n=26 Participants 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.
Ferritin	847.58 ug/L Standard Deviation 272.88	726.29 ug/L Standard Deviation 377.13

SECONDARY outcome

Timeframe: 12 months

median TSAT (%) over 12 months

Outcome measures

Measure	Epoetin Alfa n=24 Participants 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. 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	Darbepoetin Alfa n=26 Participants 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.
Transferrin Saturation (TSAT)	26.71 percentage saturation Interval 22.46 to 32.33	28.58 percentage saturation Interval 23.9 to 33.75

SECONDARY outcome

Timeframe: 12 months

median weekly iron dose (mg) over 12 months

Outcome measures

Measure	Epoetin Alfa n=24 Participants 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. 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	Darbepoetin Alfa n=26 Participants 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.
Iron Dose	40.36 mg/week Interval 20.83 to 59.9	41.67 mg/week Interval 19.53 to 70.96

SECONDARY outcome

Timeframe: 12 months

total iron cost over 12 months in Canadian dollars

Outcome measures

Measure	Epoetin Alfa n=24 Participants 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. 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	Darbepoetin Alfa n=26 Participants 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.
Iron Cost	726.56 canadian dollars Interval 375.0 to 1078.13	750 canadian dollars Interval 351.56 to 1277.34

Adverse Events

Epoetin Alfa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Darbepoetin Alfa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea Woodland

Eastern Health

Phone: 7097778146

Email: andrea.woodland@easternhealth.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place