Anemia
Conditions
Brief summary
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGmethoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
DRUGEpoetin alfa
As prescribed, iv, 3 times weekly
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months; * CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months; * average hemoglobin (Hb) 10-12 g/dL over last 3 months.
Exclusion criteria
* failed renal transplant within 12 months prior to screening; * poorly controlled hypertension; * previous treatment with Mircera.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent on Anemia Treatment Over Evaluation Period | Months 5-7 | Efficacy and pharmacoeconomics analyses were not performed. |
| Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period | Baseline, Months 5-7 | Efficacy and pharmacoeconomics analyses were not performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for AEs | Month 1 to 15 day follow up post month 7 | The adverse events are captured in the adverse event and serious adverse event section of this database. |
| The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Baseline, Month 1 to Month 7 | A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta 120-360 micrograms (iv) monthly, starting dose | 123 |
| Epoetin Alfa As prescribed, (iv), 3 times weekly | 129 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Death | 3 | 7 |
| Overall Study | early termination of the study | 67 | 80 |
| Overall Study | Lack of Efficacy | 4 | 5 |
| Overall Study | Protocol Violation | 23 | 7 |
| Overall Study | Refused Treatment | 4 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Methoxy Polyethylene Glycol-epoetin Beta | Epoetin Alfa | Total |
|---|---|---|---|
| Age Continuous | 59.3 years STANDARD_DEVIATION 13.9 | 60.0 years STANDARD_DEVIATION 14.06 | 59.7 years STANDARD_DEVIATION 13.96 |
| Sex: Female, Male Female | 52 Participants | 60 Participants | 112 Participants |
| Sex: Female, Male Male | 71 Participants | 69 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 123 | 21 / 129 |
| serious Total, serious adverse events | 24 / 123 | 38 / 129 |
Outcome results
Primary
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Time frame: Baseline, Months 5-7
Population: The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.
Primary
Time Spent on Anemia Treatment Over Evaluation Period
Efficacy and pharmacoeconomics analyses were not performed.
Time frame: Months 5-7
Population: The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.
Secondary
Number of Participants Assessed for AEs
The adverse events are captured in the adverse event and serious adverse event section of this database.
Time frame: Month 1 to 15 day follow up post month 7
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Number of Participants Assessed for AEs | 123 number of participants |
| Epoetin Alfa | Number of Participants Assessed for AEs | 129 number of participants |
Secondary
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants
A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
Time frame: Baseline, Month 1 to Month 7
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Hematocrit - low | 32 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Hemoglobin - low | 36 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Platelets - low | 9 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Creatine Phosphokinase - high | 4 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Potassium - high | 20 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Fasting Glusose - high | 20 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Phosphate - high | 52 number of participants |
| Methoxy Polyethylene Glycol-epoetin Beta | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Phosphate - low | 9 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Phosphate - low | 12 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Hematocrit - low | 24 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Potassium - high | 20 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Hemoglobin - low | 28 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Phosphate - high | 48 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Platelets - low | 4 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Fasting Glusose - high | 20 number of participants |
| Epoetin Alfa | The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | Creatine Phosphokinase - high | 8 number of participants |