The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.

Intent to treat (ITT) population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.

An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.

Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.

The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.

ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.

The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.

ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.

Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.

ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.

Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.

ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.

Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.

ITT population was defined as all participants who entered into study and took at least one dose of study drug. The ITT and safety population were identical. Data of maximum number of participants (24 participants) available at the time of analysis were analysed and 9 participants discontinued the study before this analysis.

A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).

Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.