Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin. The purpose of this extension study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease. The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests. The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.
Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.
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Gosford, New South Wales, Australia
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Melbourne, Victoria, Australia
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Reservoir, Australia
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Burgas, Bulgaria
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Dobrich, Bulgaria
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Gabrovo, Bulgaria
Change in local laboratory hemoglobin level from baseline
Time frame: Baseline up to 36 months
Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability
Time frame: Up to 36 months
Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization
Time frame: Up to 36 months
Time within hemoglobin target range (10.0 to 12.0 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 red blood cell count from baseline of this study
Time frame: Baseline up to 36 months
Change of hematocrit from baseline of this study
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
Responders in Hb levels
Time frame: Up to 36 months
Number of subjects meeting specific Hb criteria
Time frame: Baseline up to 36 months
Number of subjects with Hb values >13 g/dL or having excessive Hb increase
Time frame: Baseline up to 36 months
Number of participants with non-serious adverse events
Time frame: Up to 36 months
Change in heart rate (HR)
Time frame: Up to 36 months
Change in blood pressure (BP)
Time frame: Up to 36 months
Laboratory abnormalities
Time frame: Up to 36 months
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Karlovo, Bulgaria
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Lovech, Bulgaria
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Montana, Bulgaria
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Pazardzhik, Bulgaria
...and 95 more locations