Anemia
Conditions
Brief summary
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
Interventions
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
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 renal anemia * Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
Exclusion criteria
* Transfusion of red blood cells during previous 8 weeks * Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months * Acute or chronic bleeding requiring therapy within previous 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) | EEP (Weeks 16 to 24) | The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hb Concentration Between SVP and the EEP | SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24) | The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24. |
| Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP | EEP (Weeks 16 to 24) | The EEP was defined as Week 16 to Week 24. |
| Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP | EEP (Weeks 16 to 24) | The EEP was defined as Week 16 to Week 24. |
| Percentage of Participants With Blood Transfusion | Baseline up to Week 28 | — |
| Percentage of Participants With Dose Adjustment | Baseline up to Week 20 | A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Blood transfusion | 2 |
| Overall Study | Death | 1 |
| Overall Study | Erythropoiesis Stimulating Agent Use. | 1 |
| Overall Study | Transplantation | 1 |
Baseline characteristics
| Characteristic | Methoxy Polyethylene Glycol-epoetin Beta |
|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 16.83 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 20 |
| serious Total, serious adverse events | 6 / 20 |
Outcome results
Primary
Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Time frame: EEP (Weeks 16 to 24)
Population: The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) | 40 Percentage of participants |
Secondary
Mean Change in Hb Concentration Between SVP and the EEP
The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Time frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Mean Change in Hb Concentration Between SVP and the EEP | 0.2 g/dL | Standard Deviation 1.15 |
Secondary
Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
The EEP was defined as Week 16 to Week 24.
Time frame: EEP (Weeks 16 to 24)
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP | 36.5 Days | Standard Deviation 24.4 |
Secondary
Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
The EEP was defined as Week 16 to Week 24.
Time frame: EEP (Weeks 16 to 24)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP | 50.0 Percentage of participants |
Secondary
Percentage of Participants With Blood Transfusion
Time frame: Baseline up to Week 28
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Percentage of Participants With Blood Transfusion | 10 Percentage of participants |
Secondary
Percentage of Participants With Dose Adjustment
A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.
Time frame: Baseline up to Week 20
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Percentage of Participants With Dose Adjustment | 60 Percentage of participants |