Anemia
Conditions
Brief summary
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). 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
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
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
* chronic kidney disease, stage 3 or 4; * anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dL\]).
Exclusion criteria
* previous therapy with ESA within 12 weeks prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * red blood cell transfusions within 8 weeks before screening; * active malignant disease (except non-melanoma skin cancer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) | Baseline (Week -2 to 0) and EEP (Weeks 29 to 36) | The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achievement of Response | Baseline to Week 40 | Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL. |
| Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP | EEP (Weeks 29 to 36) | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented. |
| Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP | EEP (Weeks 29 to 36) | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented. |
| Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP | EEP (Weeks 29 to 36) | EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. |
Countries
Estonia, Finland, Latvia, Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 2 |
| Overall Study | Other | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 18.25 |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 39 |
| serious Total, serious adverse events | 11 / 39 |
Outcome results
Primary
Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
Time frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
Population: Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) | 1.32 grams per deciliter (g/dL) | Standard Deviation 0.88 |
Secondary
Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.
Time frame: EEP (Weeks 29 to 36)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP | 66.7 percentage of participants |
Secondary
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.
Time frame: EEP (Weeks 29 to 36)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP | 53.9 percentage of participants |
Secondary
Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.
Time frame: EEP (Weeks 29 to 36)
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP | 42.5 days | Standard Deviation 13.96 |
Secondary
Time to Achievement of Response
Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.
Time frame: Baseline to Week 40
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Time to Achievement of Response | 24.6 days | Standard Deviation 20.53 |