This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended 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
75
sc every month (starting dose 1.2 micrograms/kg)
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Denizli, Turkey (Türkiye)
Unnamed facility
Edirne, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Kahramanmaraş, Turkey (Türkiye)
Unnamed facility
Konya, Turkey (Türkiye)
Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period
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.
Time frame: From Baseline (Week 0) to EEP (Week 29 to Week 36)
Mean Time to Achievement of Response During the EEP
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.
Time frame: From Week 29 to Week 36
The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP
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.
Time frame: From Week 29 to Week 36
Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP
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.
Time frame: From Week 29 to Week 36
Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
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.
Time frame: Weeks 0 to Week 36
Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
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.
Time frame: Up to Week 52
Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
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.
Time frame: Up to Week 52
Mean Change From Baseline in Hb Concentration Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Hematocrit Level Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48
Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Albumin Concentration Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Creatinine Concentration Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 32, 40
Mean Change From Baseline in Ferritin Concentration Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Transferrin Saturation Over Time
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.
Time frame: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48
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