Anemia
Conditions
Brief summary
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
Recommended starting dose 1.2 micrograms/kg sc monthly
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
* adult patients, \>=18 years of age; * chronic renal anemia, with no need for dialysis expected in next 3 months; * adequate iron status.
Exclusion criteria
* previous epoetin therapy within 12 weeks prior to treatment; * transfusion of red blood cells during 2 months prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * hemolysis; * folic acid and vitamin B 12 deficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period | Baseline (Week 0) and from Week 29 to Week 36 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period | 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. |
| The Number of Participants Who Required Dose Adjustments During the Dose Titration Period | 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. |
| Time to Achievement of Response During the Efficacy Evaluation Period | 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. |
| Number of Participants With Red Blood Cells Transfusions. | Up to Week 52 | The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. |
| Mean Values of Laboratory Parameter : Hb Concentration | 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. |
| Mean Values of Laboratory Parameter : Hematocrit | 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. |
| Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | 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. |
| Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP | From Week 29 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. |
| Mean Values of Laboratory Parameter : Serum Creatinine | 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. |
| Mean Values of Laboratory Parameter: C Reactive Protein | 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. |
| Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | 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. |
| Mean Values of Laboratory Parameter: Ferritin Concentration | 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. |
| Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count | 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. |
| Mean Values of Laboratory Parameters: Transferrin Saturation | 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. |
| The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period | 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. |
| Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | 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. |
Countries
Russia
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| C.E.R.A 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. | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 2 |
| Overall Study | Dialysis | 15 |
| Overall Study | Failure to return | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Progression of Kidney Disease | 1 |
| Overall Study | Progression of Renal Failure | 1 |
| Overall Study | RBC transfusion | 1 |
| Overall Study | Refused Treatment | 8 |
| Overall Study | The patient move into other town | 1 |
| Overall Study | Transplantation | 1 |
Baseline characteristics
| Characteristic | C.E.R.A |
|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 15.41 |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 52 / 125 |
| serious Total, serious adverse events | 31 / 125 |
Outcome results
Primary
Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A | Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period | 1.75 g/dL | Standard Deviation 1.09 |
Secondary
Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A | 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
Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Baseline, n = 125 | 41.0 grams per liter | Standard Deviation 6.66 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Week 8, n = 111 | 40.5 grams per liter | Standard Deviation 6.18 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Week 16, n = 98 | 41.5 grams per liter | Standard Deviation 6.15 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Week 24, n = 96 | 40.9 grams per liter | Standard Deviation 6.28 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Week 32, n = 84 | 42.4 grams per liter | Standard Deviation 5.82 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Week 40, n = 80 | 41.3 grams per liter | Standard Deviation 7.31 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Albumin, Week 48, n = 81 | 40.7 grams per liter | Standard Deviation 5.46 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Baseline, n = 86 | 2.0 grams per liter | Standard Deviation 0.6 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Week 8, n = 74 | 2.1 grams per liter | Standard Deviation 0.47 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Week 16, n = 81 | 2.1 grams per liter | Standard Deviation 0.41 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Week 24, n = 73 | 2.2 grams per liter | Standard Deviation 0.41 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Week 32, n = 67 | 2.1 grams per liter | Standard Deviation 0.4 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Week 40, n = 59 | 2.1 grams per liter | Standard Deviation 0.46 |
| C.E.R.A | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | Transferrin, Week 48, n = 61 | 2.1 grams per liter | Standard Deviation 0.36 |
Secondary
Mean Values of Laboratory Parameter: C Reactive Protein
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Baseline, n = 123 | 4.1 milligrams per liter | Standard Deviation 10.36 |
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Week 8, n = 109 | 6.0 milligrams per liter | Standard Deviation 15.02 |
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Week 16, n = 101 | 6.5 milligrams per liter | Standard Deviation 15.14 |
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Week 24, n = 94 | 6.2 milligrams per liter | Standard Deviation 15.14 |
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Week 32, n = 81 | 4.5 milligrams per liter | Standard Deviation 7.72 |
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Week 40, n = 76 | 3.8 milligrams per liter | Standard Deviation 6 |
| C.E.R.A | Mean Values of Laboratory Parameter: C Reactive Protein | CRP, Week 48, n = 79 | 4.1 milligrams per liter | Standard Deviation 6.69 |
Secondary
Mean Values of Laboratory Parameter: Ferritin Concentration
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Baseline, n = 125 | 231.6 micrograms per liter | Standard Deviation 167.47 |
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Week 8, n = 112 | 152.4 micrograms per liter | Standard Deviation 135.2 |
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Week 16, n = 102 | 149.3 micrograms per liter | Standard Deviation 113.26 |
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Week 24, n = 94 | 154.1 micrograms per liter | Standard Deviation 116.87 |
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Week 32, n = 79 | 171.8 micrograms per liter | Standard Deviation 150.75 |
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Week 40, n = 74 | 179.6 micrograms per liter | Standard Deviation 167.06 |
| C.E.R.A | Mean Values of Laboratory Parameter: Ferritin Concentration | Ferritin, Week 48, n = 75 | 187.0 micrograms per liter | Standard Deviation 204.67 |
Secondary
Mean Values of Laboratory Parameter : Hb Concentration
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Baseline, n = 125 | 10.0 g/dL | Standard Deviation 0.58 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Week 8, n = 115 | 11.7 g/dL | Standard Deviation 1.26 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Week 16, n = 104 | 12.2 g/dL | Standard Deviation 1.17 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Week 24, n = 101 | 11.6 g/dL | Standard Deviation 1.12 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Week 32, n = 90 | 12.0 g/dL | Standard Deviation 1.12 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Week 40, n = 85 | 11.8 g/dL | Standard Deviation 1.14 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hb Concentration | Week 48, n = 82 | 11.6 g/dL | Standard Deviation 1.06 |
Secondary
Mean Values of Laboratory Parameter : Hematocrit
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Baseline, n = 124 | 0.30 fraction | Standard Deviation 0.03 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Week 8, n = 112 | 0.34 fraction | Standard Deviation 0.04 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Week 16, n = 103 | 0.36 fraction | Standard Deviation 0.04 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Week 24, n = 101 | 0.34 fraction | Standard Deviation 0.04 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Week 32, n = 90 | 0.35 fraction | Standard Deviation 0.04 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Week 40; n = 85 | 0.35 fraction | Standard Deviation 0.05 |
| C.E.R.A | Mean Values of Laboratory Parameter : Hematocrit | Week 48, n = 82 | 0.34 fraction | Standard Deviation 0.04 |
Secondary
Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Week 48, n = 81 | 16.4 micromoles/liter | Standard Deviation 5.83 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Baseline, n = 58 | 49.2 micromoles/liter | Standard Deviation 15.46 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Week 8, n = 55 | 53.7 micromoles/liter | Standard Deviation 13.57 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Week 16, n = 45 | 53.5 micromoles/liter | Standard Deviation 13.67 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Week 24, n = 44 | 54.8 micromoles/liter | Standard Deviation 13.71 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Week 32, n = 38 | 50.6 micromoles/liter | Standard Deviation 11.93 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Week 40, n = 35 | 54.0 micromoles/liter | Standard Deviation 13.35 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | TIBC, Week 48, n = 36 | 51.5 micromoles/liter | Standard Deviation 12.17 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Baseline, n = 125 | 16.0 micromoles/liter | Standard Deviation 5.35 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Week 8, n = 113 | 14.0 micromoles/liter | Standard Deviation 6.35 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Week 16, n = 103 | 14.9 micromoles/liter | Standard Deviation 6.25 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Week 24, n = 96 | 15.9 micromoles/liter | Standard Deviation 6.1 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Week 32, n = 84 | 16.6 micromoles/liter | Standard Deviation 6.22 |
| C.E.R.A | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | Iron, Week 40, n = 79 | 15.7 micromoles/liter | Standard Deviation 6.2 |
Secondary
Mean Values of Laboratory Parameter : Serum Creatinine
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.
Time frame: Baseline (Week 0), and Week 32
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameter : Serum Creatinine | Creatinine, Baseline, n = 125 | 317.8 micromoles/liter | Standard Deviation 145.41 |
| C.E.R.A | Mean Values of Laboratory Parameter : Serum Creatinine | Creatinine, Week 32, n = 84 | 361.3 micromoles/liter | Standard Deviation 160.27 |
Secondary
Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Baseline, n = 124 | 1.5 millimoles per litre | Standard Deviation 0.36 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Week 8, n = 113 | 1.6 millimoles per litre | Standard Deviation 0.38 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Week 16, n = 102 | 1.5 millimoles per litre | Standard Deviation 0.47 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Week 24, n = 94 | 1.6 millimoles per litre | Standard Deviation 0.37 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Week 32, n = 85 | 1.6 millimoles per litre | Standard Deviation 0.45 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Week 40, n = 80 | 1.6 millimoles per litre | Standard Deviation 0.46 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Phosphate, Week 48, n = 79 | 1.6 millimoles per litre | Standard Deviation 0.49 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Baseline, n = 125 | 5.1 millimoles per litre | Standard Deviation 0.6 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Week 8, n=113 | 5.1 millimoles per litre | Standard Deviation 0.66 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Week 16, n = 102 | 5.1 millimoles per litre | Standard Deviation 0.59 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Week 24, n= 96 | 5.0 millimoles per litre | Standard Deviation 0.75 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Week 32, n = 85 | 5.1 millimoles per litre | Standard Deviation 0.59 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Week 40, n = 79 | 5.1 millimoles per litre | Standard Deviation 0.56 |
| C.E.R.A | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | Potassium, Week 48, n = 80 | 5.2 millimoles per litre | Standard Deviation 0.76 |
Secondary
Mean Values of Laboratory Parameters: Transferrin Saturation
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Baseline, n = 125 | 32.1 percentage of saturation | Standard Deviation 18.59 |
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Week 8, n = 113 | 25.7 percentage of saturation | Standard Deviation 13.57 |
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Week 16, n = 103 | 27.8 percentage of saturation | Standard Deviation 12.14 |
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Week 24, n = 96 | 30.1 percentage of saturation | Standard Deviation 12.02 |
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Week 32, n = 84 | 32.1 percentage of saturation | Standard Deviation 13.82 |
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Week 40, n = 79 | 30.0 percentage of saturation | Standard Deviation 14.37 |
| C.E.R.A | Mean Values of Laboratory Parameters: Transferrin Saturation | TSAT, Week 48, n = 81 | 32.7 percentage of saturation | Standard Deviation 16.72 |
Secondary
Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count
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.
Time frame: Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48
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 n represents the number of participants analyzed at a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count | WBC, Week 16, n = 103 | 7.1 10^9 cells/liter | Standard Deviation 2.2 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | 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 |
| C.E.R.A | Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count | Thrombocyte, Week 40, n = 80 | 226.1 10^9 cells/liter | Standard Deviation 53.3 |
| C.E.R.A | 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
Number of Participants With Red Blood Cells Transfusions.
The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A | Number of Participants With Red Blood Cells Transfusions. | 1 participants |
Secondary
Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A | 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 |
Secondary
The Number of Participants Who Required Dose Adjustments During the Dose Titration Period
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.
Time frame: From Week 0 to Week 28 (DTP)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A | The Number of Participants Who Required Dose Adjustments During the Dose Titration Period | 61 participants |
Secondary
The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
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.
Time frame: From Week 29 to Week 36 (EEP)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C.E.R.A | The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period | 34 participants |
Secondary
Time to Achievement of Response During the Efficacy Evaluation Period
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C.E.R.A | Time to Achievement of Response During the Efficacy Evaluation Period | 30.8 days | Standard Deviation 27.21 |