This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Differing doses and frequencies of sc administration
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Jose, California, United States
Unnamed facility
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -1).
Time frame: From Baseline (Day -28 to Day 1) to Week 126
Mean Change in Pulse Rate
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Boston, Massachusetts, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Morgantown, West Virginia, United States
Unnamed facility
Berlin, Germany
Unnamed facility
Mannheim, Germany
Unnamed facility
Villingen-Schwenningen, Germany
Unnamed facility
Wiesloch, Germany
...and 13 more locations
Mean change in pulse rate was reported.
Time frame: Up to Week 126
Number of Participants With Marked Laboratory Abnormalities
Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high \>25 units per litre (U/L), albumin (low \< 31 grams per litre \[g/L\]), total protein (\< 60 g/L), phosphate (high \>1.45 millimoles per litre \[mmol/L\]); Low \<0.84 mmol/L), potassium (high \>5 mmol/L; Low \<3.5 mmol/L), platelets (low:\<150×10\^9/L), White blood cells (\[WBCs\]); high: 10.8×10\^9/L and Low:4.3×10\^9/L), basophils (high:\>0.15×10\^9/L), eosinophils (high:\>0.70×10\^9/L), lymphocytes (low:\<1.50×10\^9/L), and neutrophils (low:\<1.83×10\^9/L).
Time frame: Up to Week 126
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
An Adverse Events (AEs) is defined as 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. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Time frame: Up to Week 126