Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.

Per protocol (PP) population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.

Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.

PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.

The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.

PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up variable were included. Participants with less than three recorded Hb values during EEP; participants missing administration of C.E.R.A. during weeks 28-36; participants with inadequate iron status, were excluded.

Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.

PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.

Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.

PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.

Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants who entered a particular phase is determined by 'n'.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.

Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.

Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.

Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.