Anemia
Conditions
Brief summary
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
Interventions
DRUGMethoxy polyethylene glycol-epoetin beta
Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
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
* Adults greater than or equal to (≥) 18 years of age * Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months * Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
Exclusion criteria
* Transfusion of red blood cells during previous 8 weeks * Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months * Significant acute or chronic bleeding during previous 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP | Weeks 16 to 24 | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hb Value From Baseline to the EEP | Baseline and Weeks 16 to 24 | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL. |
| Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period | Weeks 16 to 24 and Weeks 0 to 48 | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks. |
| Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48 | Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit. |
| Percentage of Participants With Cycles or Excursions | Weeks 4 to 44 | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (\>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) \>1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated. |
| Percentage of Participants With Up Excursions | Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44 | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb \>1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44. |
| Percentage of Participants With Hb Values Within Target Range During the EEP | Weeks 16 to 24 | During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined. |
| Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48 | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. |
| Number of Dose Adjustments of Mircera/CERA | Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48 | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48. |
| Absolute Change in Dose of Mircera/CERA by Study Week | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants. |
| Percent Change in Dose of Mircera/CERA by Study Week | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as \[(current dose minus previous week dose) divided by previous week dose\] multiplied by 100, and averaged among all participants. |
| Percentage of Participants Requiring Blood Transfusions | Weeks 0 to 48 | The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated. |
| Percentage of Participants With Down Excursions | Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44 | Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb \>1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mircera in CKD-Related Anemia Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Death | 9 |
| Overall Study | Other | 4 |
| Overall Study | Renal Transplantation | 10 |
| Overall Study | Treatment Refusal | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Mircera in CKD-Related Anemia |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 96 |
| serious Total, serious adverse events | 48 / 96 |
Outcome results
Primary
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Time frame: Weeks 16 to 24
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP | 50.0 percentage of participants |
Secondary
Absolute Change in Dose of Mircera/CERA by Study Week
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 4, Dose Decrease (n=25) | 25.8 mcg | Standard Deviation 11.9 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 4, Dose Increase (n=9) | 37.8 mcg | Standard Deviation 17.2 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 8, Dose Decrease (n=32) | 28.4 mcg | Standard Deviation 12.3 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 8, Dose Increase (n=14) | 42.9 mcg | Standard Deviation 24.6 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 12, Dose Decrease (n=21) | 24.5 mcg | Standard Deviation 3.5 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 12, Dose Increase (n=8) | 52.5 mcg | Standard Deviation 21.7 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 16, Dose Decrease (n=20) | 24.0 mcg | Standard Deviation 2.6 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 16, Dose Increase (n=8) | 47.5 mcg | Standard Deviation 29 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 20, Dose Decrease (n=11) | 29.1 mcg | Standard Deviation 15.3 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 20, Dose Increase (n=10) | 34.5 mcg | Standard Deviation 11.2 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 24, Dose Decrease (n=18) | 29.0 mcg | Standard Deviation 12.2 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 24, Dose Increase (n=10) | 50.5 mcg | Standard Deviation 26 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 28, Dose Decrease (n=13) | 38.5 mcg | Standard Deviation 22 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 28, Dose Increase (n=7) | 35.0 mcg | Standard Deviation 20.2 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 32, Dose Decrease (n=10) | 27.0 mcg | Standard Deviation 8.8 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 32, Dose Increase (n=8) | 37.5 mcg | Standard Deviation 19.1 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 36, Dose Decrease (n=10) | 28.5 mcg | Standard Deviation 11.6 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 36, Dose Increase (n=2) | 75.0 mcg | Standard Deviation 35.4 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 40, Dose Decrease (n=11) | 37.3 mcg | Standard Deviation 26.8 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 40, Dose Increase (n=4) | 22.5 mcg | Standard Deviation 2.9 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 44, Dose Decrease (n=2) | 18.5 mcg | Standard Deviation 2.1 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 44, Dose Increase (n=5) | 32.0 mcg | Standard Deviation 10.9 |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 48, Dose Decrease (n=0) | NA mcg | — |
| Mircera in CKD-Related Anemia | Absolute Change in Dose of Mircera/CERA by Study Week | Week 48, Dose Increase (n=2) | 40.0 mcg | Standard Deviation 14.1 |
Secondary
Change in Hb Value From Baseline to the EEP
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL.
Time frame: Baseline and Weeks 16 to 24
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Change in Hb Value From Baseline to the EEP | 0.4 g/dL | Standard Deviation 0.9 |
Secondary
Number of Dose Adjustments of Mircera/CERA
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.
Time frame: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera in CKD-Related Anemia | Number of Dose Adjustments of Mircera/CERA | Weeks 4 to 20 (n=95) | 2.0 dose adjustments | Standard Deviation 1.3 |
| Mircera in CKD-Related Anemia | Number of Dose Adjustments of Mircera/CERA | Weeks 24 to 48 (n=76) | 5.6 dose adjustments | Standard Deviation 1.3 |
| Mircera in CKD-Related Anemia | Number of Dose Adjustments of Mircera/CERA | Weeks 4 to 48 (n=95) | 3.3 dose adjustments | Standard Deviation 2 |
Secondary
Percentage of Participants Requiring Blood Transfusions
The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.
Time frame: Weeks 0 to 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants Requiring Blood Transfusions | 3.2 percentage of participants |
Secondary
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.
Time frame: Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Any Dose Adjustment, Weeks 4 to 20 (n=95) | 84.2 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Decreased Dose, Weeks 4 to 20 (n=75) | 69.3 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Increased Dose, Weeks 4 to 20 (n=75) | 43.3 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Dose Not Performed, Weeks 4 to 20 (n=95) | 34.7 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Any Dose Adjustment, Weeks 24 to 48 (n=76) | 100 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Decreased Dose, Weeks 24 to 48 (n=50) | 74.0 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Increased Dose, Weeks 24 to 48 (n=50) | 46.0 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Dose Not Performed, Weeks 24 to 48 (n=76) | 30.3 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Any Dose Adjustment, Weeks 4 to 48 (n=95) | 96.8 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Decreased Dose, Weeks 4 to 48 (n=94) | 84.0 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Increased Dose, Weeks 4 to 48 (n=94) | 71.3 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA | Dose Not Performed, Weeks 4 to 48 (n=95) | 47.4 percentage of participants |
Secondary
Percentage of Participants With Cycles or Excursions
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (\>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) \>1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated.
Time frame: Weeks 4 to 44
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants With Cycles or Excursions | At Least One Cycle | 5.3 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Cycles or Excursions | At Least One Excursion | 60.0 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Cycles or Excursions | At Least One Up Excursion | 46.3 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Cycles or Excursions | At Least One Down Excursion | 18.9 percentage of participants |
Secondary
Percentage of Participants With Down Excursions
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb \>1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44.
Time frame: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one down excursion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants With Down Excursions | Weeks 4 to 16 | 16.7 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Down Excursions | Weeks 16 to 24 | 11.1 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Down Excursions | Weeks 24 to 44 | 72.2 percentage of participants |
Secondary
Percentage of Participants With Hb Values Within Target Range During the EEP
During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.
Time frame: Weeks 16 to 24
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Values Within Target Range During the EEP | At Least One Hb Value (n=80) | 78.8 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Values Within Target Range During the EEP | At Least Two Hb Values (n=77) | 49.4 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Values Within Target Range During the EEP | All Three Hb Values (n=74) | 23.0 percentage of participants |
Secondary
Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.
Time frame: Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 16 (n=80) | 37.5 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 20 (n=76) | 35.5 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 24 (n=75) | 44.0 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 28 (n=73) | 39.7 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 32 (n=72) | 44.4 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 36 (n=68) | 51.5 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 40 (n=65) | 44.6 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 44 (n=63) | 44.4 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit | Week 48 (n=62) | 38.7 percentage of participants |
Secondary
Percentage of Participants With Up Excursions
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb \>1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44.
Time frame: Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one up excursion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera in CKD-Related Anemia | Percentage of Participants With Up Excursions | Weeks 4 to 16 | 31.8 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Up Excursions | Weeks 16 to 24 | 45.5 percentage of participants |
| Mircera in CKD-Related Anemia | Percentage of Participants With Up Excursions | Weeks 24 to 44 | 22.7 percentage of participants |
Secondary
Percent Change in Dose of Mircera/CERA by Study Week
Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as \[(current dose minus previous week dose) divided by previous week dose\] multiplied by 100, and averaged among all participants.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 4, Dose Decrease (n=25) | 23.7 percent change in dose | Standard Deviation 9 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 4, Dose Increase (n=9) | 22.2 percent change in dose | Standard Deviation 6.7 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 8, Dose Decrease (n=32) | 33.3 percent change in dose | Standard Deviation 22.2 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 8, Dose Increase (n=14) | 21.4 percent change in dose | Standard Deviation 4.9 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 12, Dose Decrease (n=21) | 30.3 percent change in dose | Standard Deviation 10 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 12, Dose Increase (n=8) | 22.0 percent change in dose | Standard Deviation 2.3 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 16, Dose Decrease (n=20) | 41.1 percent change in dose | Standard Deviation 14 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 16, Dose Increase (n=8) | 25.6 percent change in dose | Standard Deviation 7.7 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 20, Dose Decrease (n=11) | 57.6 percent change in dose | Standard Deviation 60.7 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 20, Dose Increase (n=10) | 21.5 percent change in dose | Standard Deviation 4.6 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 24, Dose Decrease (n=18) | 45.0 percent change in dose | Standard Deviation 24.8 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 24, Dose Increase (n=10) | 29.6 percent change in dose | Standard Deviation 14.5 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 28, Dose Decrease (n=13) | 38.5 percent change in dose | Standard Deviation 12 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 28, Dose Increase (n=7) | 29.7 percent change in dose | Standard Deviation 7.1 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 32, Dose Decrease (n=10) | 36.5 percent change in dose | Standard Deviation 16.4 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 32, Dose Increase (n=8) | 24.6 percent change in dose | Standard Deviation 6.2 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 36, Dose Decrease (n=10) | 43.7 percent change in dose | Standard Deviation 15.5 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 36, Dose Increase (n=2) | 22.5 percent change in dose | Standard Deviation 3.5 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 40, Dose Decrease (n=11) | 51.6 percent change in dose | Standard Deviation 29.3 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 40, Dose Increase (n=4) | 26.7 percent change in dose | Standard Deviation 9.7 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 44, Dose Decrease (n=2) | 35.8 percent change in dose | Standard Deviation 22.3 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 44, Dose Increase (n=5) | 24.0 percent change in dose | Standard Deviation 8.9 |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 48, Dose Decrease (n=0) | NA percent change in dose | — |
| Mircera in CKD-Related Anemia | Percent Change in Dose of Mircera/CERA by Study Week | Week 48, Dose Increase (n=2) | 22.5 percent change in dose | Standard Deviation 3.5 |
Secondary
Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.
Time frame: Weeks 16 to 24 and Weeks 0 to 48
Population: ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera in CKD-Related Anemia | Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period | EEP (Weeks 16 to 24; n=80) | 5.9 weeks | Standard Deviation 4.2 |
| Mircera in CKD-Related Anemia | Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period | Overall Study (Weeks 0 to 48; n=94) | 22.0 weeks | Standard Deviation 13.8 |