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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Recommended starting dose 1.2 micrograms/kg sc monthly
Unnamed facility
Irkutsk, Russia
Unnamed facility
Khanty-Mansiysk, Russia
Unnamed facility
Moscow, Russia
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
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
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
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)
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
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Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Moscow, Russia
Unnamed facility
Nizhny Novgorod, Russia
Unnamed facility
Nizhny Novgorod, Russia
Unnamed facility
Omsk, Russia
Unnamed facility
Orenburg, Russia
...and 9 more locations
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
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
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
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
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
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
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
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
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
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
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
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)