Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
Unnamed facility
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Time frame: Baseline and weeks 14 to 17
Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
Time frame: From week 14 to 17
Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
Time frame: From week 14 to 17
Change from baseline in Hb during active treatment
Time frame: Baseline and weeks 14 to 17
Number of patients with hemoglobin levels outside the target range
Time frame: From week 14 to 17
Dose level in the evaluation period
Time frame: Up to 16 weeks
Duration of exposure on each dose level
Time frame: Up to 16 weeks
Number of subjects requiring titration of dose
Time frame: Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Time frame: Up to 16 weeks
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Azusa, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Lynwood, California, United States
Unnamed facility
Northridge, California, United States
Unnamed facility
San Dimas, California, United States
Unnamed facility
Whittier, California, United States
Unnamed facility
Whittier, California, United States
Unnamed facility
New Port Richey, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
...and 25 more locations