A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.

Time frame: Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)

Population: ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.

Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.

Time frame: Baseline up to Week 28

Population: Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.

The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.

Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)

Population: ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.

Percentage of participants having at least one Hb value greater than (\>) 12 g/dL during the first 8 weeks of the study was reported.

Time frame: Baseline to Week 8

Population: ITT population. Here, N=number of participants evaluable for this measure.

The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and \>=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were \>=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.

Time frame: Baseline to Week 28

Population: ITT population. Here, N=number of participants analyzed for this measure.

The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.

Time frame: Baseline up to Week 28

Population: ITT population.

A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and \>=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were \>=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.

Time frame: Baseline to Week 28

Population: ITT population.

Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb \>=1.0 g/dL from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without RBC transfusion before response.

Time frame: Baseline up to Week 28

Population: ITT population.