Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Subjects will continue with the same treatment they were receiving in the parent study (16208). BAY85-3934 will be administered daily as oral tablets. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits, the dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose. Total treatment time is up to 36 months. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months.
Unnamed facility
Azusa, California, United States
Unnamed facility
Long Beach, California, United States
Change in local laboratory hemoglobin level from baseline
Time frame: Baseline up to 36 months
Number of participants with serious adverse events as a measure of safety and tolerability
Time frame: Up to 36 months
Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)
Time frame: Up to 36 months
Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)
Time frame: Up to 36 months
Duration of treatment exposure
Time frame: Up to 36 months
Number of subjects requiring titration of dose
Time frame: Up to 36 months
Change of reticulocyte count from baseline of this study
Time frame: Baseline up to 36 months
Change of reticulocyte count from baseline of study 16208
Time frame: Baseline up to 36 months
Change of red blood cell count from baseline of this study
Time frame: Baseline up to 36 months
Change of red blood cell count from baseline of study 16208
Time frame: Baseline up to 36 months
Change of hematocrit from baseline of this study
Time frame: Baseline up to 36 months
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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
Unnamed facility
Detroit, Michigan, United States
...and 16 more locations
Change of hematocrit from baseline of study 16208
Time frame: Baseline up to 36 months
Change of central laboratory hemoglobin level from baseline of this study
Time frame: Baseline up to 36 months
Change of central laboratory hemoglobin level from baseline of study 16208
Time frame: Baseline up to 36 months