Anemia
Conditions
Brief summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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 [Mircera]
sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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; * chronic renal anemia; * continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Exclusion criteria
* transfusion of red blood cells during previous 2 months; * poorly controlled hypertension; * significant acute or chronic bleeding; * active malignant disease (except non-melanoma skin cancer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) | EEP (Weeks 17 to 24) | The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Concentration Between SVP and the EEP | SVP (Baseline), and EEP (Weeks 17 to 24) | Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24. |
| Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP | EEP (Weeks 17 to 24) | EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson. |
| Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP | Weeks 1 to 24 | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. |
| Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP | Weeks 1 to 24 | DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24. |
| Average Dose of Mircera Per Month | Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mircera Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels. | 191 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 5 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Mircera |
|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 90 / 191 |
| serious Total, serious adverse events | 31 / 191 |
Outcome results
Primary
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Time frame: EEP (Weeks 17 to 24)
Population: Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera | Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) | 53.9 percentage of participants |
Secondary
Average Dose of Mircera Per Month
Time frame: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24
Population: ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera | Average Dose of Mircera Per Month | Week 0-4 | 121.2 microgram (mcg) | Standard Deviation 9.8 |
| Mircera | Average Dose of Mircera Per Month | Week 4-8 | 100.8 microgram (mcg) | Standard Deviation 33.3 |
| Mircera | Average Dose of Mircera Per Month | Week 8-12 | 78.8 microgram (mcg) | Standard Deviation 45.8 |
| Mircera | Average Dose of Mircera Per Month | Week 12-16 | 72.7 microgram (mcg) | Standard Deviation 46.6 |
| Mircera | Average Dose of Mircera Per Month | Week 16-20 | 66.9 microgram (mcg) | Standard Deviation 48 |
| Mircera | Average Dose of Mircera Per Month | Week 20-24 | 66.2 microgram (mcg) | Standard Deviation 47.1 |
Secondary
Change in Hemoglobin Concentration Between SVP and the EEP
Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Time frame: SVP (Baseline), and EEP (Weeks 17 to 24)
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mircera | Change in Hemoglobin Concentration Between SVP and the EEP | 0.55 grams per deciliter (g/dL) | Standard Deviation 0.93 |
Secondary
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Time frame: EEP (Weeks 17 to 24)
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera | Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP | 73.0 percentage of participants |
Secondary
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time frame: Weeks 1 to 24
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera | Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP | 87.2 percentage of participants |
Secondary
Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time frame: Weeks 1 to 24
Population: ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mircera | Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP | 103.6 days | Standard Deviation 41.9 |