This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)
Unnamed facility
Agadir, Morocco
Unnamed facility
Casablanca, Morocco
Unnamed facility
Casablanca, Morocco
Unnamed facility
Casablanca, Morocco
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
Time frame: EEP (Week 17 to Week 24)
Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.
Time frame: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.
Time frame: EEP (Week 17 to Week 24)
Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.
Time frame: EEP (Week 17 to Week 24)
Number of Participants With Any Adverse Events or Serious Adverse Events
An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.
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Unnamed facility
FÉS, Morocco
Unnamed facility
Khouribga, Morocco
Unnamed facility
Marrakesh, Morocco
Unnamed facility
Méknés, Morocco
Unnamed facility
Rabat, Morocco
Unnamed facility
Rabat, Morocco
...and 2 more locations
Time frame: Up to Week 52
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either \> or = 13 g/dL or \< or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was \> or =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 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was \>1 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 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Time frame: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.
Time frame: Up to Week 52
Mean Hemoglobin Levels Over Time
The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Hematocrit Levels Over Time
The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Albumin Levels Over Time
The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean White Blood Cells and Thrombocytes Over Time
The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Phosphate and Potassium Levels Over Time
The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean C-Reactive Protein Levels Over Time
The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Ferritin Levels Over Time
The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Transferrin Saturation Levels Over Time
The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Pulse Rate Over Time
Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Blood Pressure Over Time
Mean change in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Weight Over Time
Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).
Time frame: Week 16 and Week 48