Trial Outcomes & Findings for A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients. (NCT NCT00576628)

Last Updated: 2016-11-30

Results Overview

The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

133 participants

Primary outcome timeframe

Baseline (Week 0) and from Week 29 to Week 36

Results posted on

2016-11-30

Participant Flow

A total of 133 eligible participants were enrolled in the study conducted from 8 May 2008 to 31 March 2010 across 19 centers in Russia.

Out of total 133 enrolled participants who met the eligibility criteria, eight participants did not receive active study drug and were not included in any analysis population.

Participant milestones

Participant milestones
Measure	C.E.R.A Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
Overall Study STARTED	125
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	C.E.R.A Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
Overall Study Adverse Event	11
Overall Study Death	2
Overall Study Failure to return	1
Overall Study Refused Treatment	8
Overall Study Pregnancy	1
Overall Study RBC transfusion	1
Overall Study Progression of Kidney Disease	1
Overall Study Progression of Renal Failure	1
Overall Study The patient move into other town	1
Overall Study Transplantation	1
Overall Study Dialysis	15

Baseline Characteristics

A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Age, Continuous	46.8 years STANDARD_DEVIATION 15.41 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and from Week 29 to Week 36

Population: The primary analysis was performed on per protocol (PP) population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.

Outcome measures

Outcome measures
Measure	C.E.R.A n=66 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period	1.75 g/dL Standard Deviation 1.09

SECONDARY outcome

Timeframe: From Week 29 to Week 36

Population: The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.

Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.

Outcome measures

Outcome measures
Measure	C.E.R.A n=66 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP	66.7 percentage of participants Interval 54.0 to 77.8

SECONDARY outcome

Timeframe: From Week 29 to Week 36

The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.

Outcome measures

Outcome measures
Measure	C.E.R.A n=66 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period	37.4 days Standard Deviation 18.98

SECONDARY outcome

Timeframe: From Week 0 to Week 28 (DTP)

The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.

Outcome measures

Outcome measures
Measure	C.E.R.A n=66 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
The Number of Participants Who Required Dose Adjustments During the Dose Titration Period	61 participants

SECONDARY outcome

Timeframe: From Week 29 to Week 36

The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.

Outcome measures

Outcome measures
Measure	C.E.R.A n=66 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Time to Achievement of Response During the Efficacy Evaluation Period	30.8 days Standard Deviation 27.21

SECONDARY outcome

Timeframe: Up to Week 52

Population: The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.

The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Number of Participants With Red Blood Cells Transfusions.	1 participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter : Hb Concentration Week 24, n = 101	11.6 g/dL Standard Deviation 1.12
Mean Values of Laboratory Parameter : Hb Concentration Baseline, n = 125	10.0 g/dL Standard Deviation 0.58
Mean Values of Laboratory Parameter : Hb Concentration Week 8, n = 115	11.7 g/dL Standard Deviation 1.26
Mean Values of Laboratory Parameter : Hb Concentration Week 16, n = 104	12.2 g/dL Standard Deviation 1.17
Mean Values of Laboratory Parameter : Hb Concentration Week 32, n = 90	12.0 g/dL Standard Deviation 1.12
Mean Values of Laboratory Parameter : Hb Concentration Week 40, n = 85	11.8 g/dL Standard Deviation 1.14
Mean Values of Laboratory Parameter : Hb Concentration Week 48, n = 82	11.6 g/dL Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter : Hematocrit Baseline, n = 124	0.30 fraction Standard Deviation 0.03
Mean Values of Laboratory Parameter : Hematocrit Week 8, n = 112	0.34 fraction Standard Deviation 0.04
Mean Values of Laboratory Parameter : Hematocrit Week 16, n = 103	0.36 fraction Standard Deviation 0.04
Mean Values of Laboratory Parameter : Hematocrit Week 24, n = 101	0.34 fraction Standard Deviation 0.04
Mean Values of Laboratory Parameter : Hematocrit Week 32, n = 90	0.35 fraction Standard Deviation 0.04
Mean Values of Laboratory Parameter : Hematocrit Week 40; n = 85	0.35 fraction Standard Deviation 0.05
Mean Values of Laboratory Parameter : Hematocrit Week 48, n = 82	0.34 fraction Standard Deviation 0.04

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Week 40, n = 80	1.6 millimoles per litre Standard Deviation 0.46
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Week 48, n = 79	1.6 millimoles per litre Standard Deviation 0.49
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Baseline, n = 124	1.5 millimoles per litre Standard Deviation 0.36
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Week 8, n = 113	1.6 millimoles per litre Standard Deviation 0.38
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Week 16, n = 102	1.5 millimoles per litre Standard Deviation 0.47
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Week 24, n = 94	1.6 millimoles per litre Standard Deviation 0.37
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Phosphate, Week 32, n = 85	1.6 millimoles per litre Standard Deviation 0.45
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Baseline, n = 125	5.1 millimoles per litre Standard Deviation 0.60
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Week 8, n=113	5.1 millimoles per litre Standard Deviation 0.66
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Week 16, n = 102	5.1 millimoles per litre Standard Deviation 0.59
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Week 24, n= 96	5.0 millimoles per litre Standard Deviation 0.75
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Week 32, n = 85	5.1 millimoles per litre Standard Deviation 0.59
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Week 40, n = 79	5.1 millimoles per litre Standard Deviation 0.56
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration Potassium, Week 48, n = 80	5.2 millimoles per litre Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Week 32, n = 84	16.6 micromoles/liter Standard Deviation 6.22
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Week 40, n = 79	15.7 micromoles/liter Standard Deviation 6.20
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Week 48, n = 81	16.4 micromoles/liter Standard Deviation 5.83
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Week 32, n = 38	50.6 micromoles/liter Standard Deviation 11.93
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Baseline, n = 125	16.0 micromoles/liter Standard Deviation 5.35
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Week 8, n = 113	14.0 micromoles/liter Standard Deviation 6.35
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Week 16, n = 103	14.9 micromoles/liter Standard Deviation 6.25
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity Iron, Week 24, n = 96	15.9 micromoles/liter Standard Deviation 6.10
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Baseline, n = 58	49.2 micromoles/liter Standard Deviation 15.46
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Week 8, n = 55	53.7 micromoles/liter Standard Deviation 13.57
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Week 16, n = 45	53.5 micromoles/liter Standard Deviation 13.67
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Week 24, n = 44	54.8 micromoles/liter Standard Deviation 13.71
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Week 40, n = 35	54.0 micromoles/liter Standard Deviation 13.35
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity TIBC, Week 48, n = 36	51.5 micromoles/liter Standard Deviation 12.17

SECONDARY outcome

Timeframe: Baseline (Week 0), and Week 32

The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter : Serum Creatinine Creatinine, Baseline, n = 125	317.8 micromoles/liter Standard Deviation 145.41
Mean Values of Laboratory Parameter : Serum Creatinine Creatinine, Week 32, n = 84	361.3 micromoles/liter Standard Deviation 160.27

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Week 16, n = 101	6.5 milligrams per liter Standard Deviation 15.14
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Week 24, n = 94	6.2 milligrams per liter Standard Deviation 15.14
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Week 32, n = 81	4.5 milligrams per liter Standard Deviation 7.72
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Week 40, n = 76	3.8 milligrams per liter Standard Deviation 6.00
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Week 48, n = 79	4.1 milligrams per liter Standard Deviation 6.69
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Baseline, n = 123	4.1 milligrams per liter Standard Deviation 10.36
Mean Values of Laboratory Parameter: C Reactive Protein CRP, Week 8, n = 109	6.0 milligrams per liter Standard Deviation 15.02

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Week 40, n = 59	2.1 grams per liter Standard Deviation 0.46
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Week 48, n = 61	2.1 grams per liter Standard Deviation 0.36
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Baseline, n = 125	41.0 grams per liter Standard Deviation 6.66
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Week 8, n = 111	40.5 grams per liter Standard Deviation 6.18
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Week 16, n = 98	41.5 grams per liter Standard Deviation 6.15
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Week 24, n = 96	40.9 grams per liter Standard Deviation 6.28
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Week 32, n = 84	42.4 grams per liter Standard Deviation 5.82
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Week 40, n = 80	41.3 grams per liter Standard Deviation 7.31
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Albumin, Week 48, n = 81	40.7 grams per liter Standard Deviation 5.46
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Baseline, n = 86	2.0 grams per liter Standard Deviation 0.60
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Week 8, n = 74	2.1 grams per liter Standard Deviation 0.47
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Week 16, n = 81	2.1 grams per liter Standard Deviation 0.41
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Week 24, n = 73	2.2 grams per liter Standard Deviation 0.41
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration Transferrin, Week 32, n = 67	2.1 grams per liter Standard Deviation 0.40

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Baseline, n = 125	231.6 micrograms per liter Standard Deviation 167.47
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Week 8, n = 112	152.4 micrograms per liter Standard Deviation 135.20
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Week 16, n = 102	149.3 micrograms per liter Standard Deviation 113.26
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Week 24, n = 94	154.1 micrograms per liter Standard Deviation 116.87
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Week 32, n = 79	171.8 micrograms per liter Standard Deviation 150.75
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Week 40, n = 74	179.6 micrograms per liter Standard Deviation 167.06
Mean Values of Laboratory Parameter: Ferritin Concentration Ferritin, Week 48, n = 75	187.0 micrograms per liter Standard Deviation 204.67

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Baseline, n = 125	7.1 10^9 cells/liter Standard Deviation 2.22
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Week 8, n = 114	7.2 10^9 cells/liter Standard Deviation 2.13
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Week 16, n = 103	7.1 10^9 cells/liter Standard Deviation 2.20
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Week 24, n = 97	7.1 10^9 cells/liter Standard Deviation 1.79
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Week 32, n = 86	7.2 10^9 cells/liter Standard Deviation 1.76
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Week 40, n = 80	6.9 10^9 cells/liter Standard Deviation 1.45
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count WBC, Week 48, n = 81	6.6 10^9 cells/liter Standard Deviation 1.56
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Baseline, n = 125	255.4 10^9 cells/liter Standard Deviation 75.12
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Week 8, n = 110	240.2 10^9 cells/liter Standard Deviation 69.63
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Week 16, n = 102	237.3 10^9 cells/liter Standard Deviation 70.46
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Week 24, n = 97	237.2 10^9 cells/liter Standard Deviation 66.31
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Week 32, n = 85	237.0 10^9 cells/liter Standard Deviation 72.07
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Week 40, n = 80	226.1 10^9 cells/liter Standard Deviation 53.30
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count Thrombocyte, Week 48, n = 81	222.5 10^9 cells/liter Standard Deviation 58.92

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48

The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.

Outcome measures

Outcome measures
Measure	C.E.R.A n=125 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Week 32, n = 84	32.1 percentage of saturation Standard Deviation 13.82
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Week 40, n = 79	30.0 percentage of saturation Standard Deviation 14.37
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Week 48, n = 81	32.7 percentage of saturation Standard Deviation 16.72
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Baseline, n = 125	32.1 percentage of saturation Standard Deviation 18.59
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Week 8, n = 113	25.7 percentage of saturation Standard Deviation 13.57
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Week 16, n = 103	27.8 percentage of saturation Standard Deviation 12.14
Mean Values of Laboratory Parameters: Transferrin Saturation TSAT, Week 24, n = 96	30.1 percentage of saturation Standard Deviation 12.02

SECONDARY outcome

Timeframe: From Week 29 to Week 36 (EEP)

The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.

Outcome measures

Outcome measures
Measure	C.E.R.A n=66 Participants Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period	34 participants

Adverse Events

C.E.R.A

Serious events: 31 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	C.E.R.A n=125 participants at risk Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Cardiac disorders Acute myocardial infarction	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Cardiac disorders Myocardial Infarction	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Eye disorders Eye haemorrhage	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Eye disorders Visual acuity reduced	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Gastrointestinal disorders Gastric ulcer	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Gastrointestinal disorders Pancreatitis	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
General disorders General physical health deterioration	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Hepatobiliary disorders Cholecystitis chronic	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Infections and infestations Cellulitis	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Nervous system disorders Cerebrovascular accident	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Nervous system disorders Coma	1.6% 2/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Nervous system disorders Diabetic autonomic neuropathy	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Nervous system disorders Ischaemic stroke	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Nervous system disorders Thrombotic stroke	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Nervous system disorders Vascular encephalopathy	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Renal and urinary disorders Azotaemia	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Renal and urinary disorders Calculus urinary	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Renal and urinary disorders Glomerulonephritis rapidly progressive	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Renal and urinary disorders Renal failure	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Renal and urinary disorders Renal failure chronic	7.2% 9/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Renal and urinary disorders Renal impairment	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Surgical and medical procedures Haemodialysis	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Vascular disorders Hypertension	1.6% 2/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Vascular disorders Hypertensive crisis	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Vascular disorders Hypotension	0.80% 1/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.

Other adverse events

Other adverse events
Measure	C.E.R.A n=125 participants at risk Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
Vascular disorders Hypertension	22.4% 28/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Infections and infestations Influenza	10.4% 13/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
General disorders Asthenia	7.2% 9/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Metabolism and nutrition disorders Hyperkalaemia	6.4% 8/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.
Investigations Blood Pressure Increased	5.6% 7/125 • Up to Week 52 An adverse event (AE) was defined as any unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily, whether or not considered related to the treatment. Adverse event was summarized in participants who have been treated with at least one dose of the trial medication.

Additional Information

Roche Trial Information Hotline

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Phone: +41 61 6878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER