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 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 study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 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 3 hospitals in the UK. Bayer HealthCare AG is funding this research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
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Gosford, New South Wales, Australia
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Reservoir, Victoria, Australia
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Dobrich, Bulgaria
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Lovech, Bulgaria
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Montana, Bulgaria
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Pazardzhik, Bulgaria
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Time frame: Baseline and week 12 to 16
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Time frame: Up to 16 weeks
Change in hemoglobin level
Time frame: Baseline up to 16 weeks
Number of patients with hemoglobin levels outside the target range
Time frame: Week 12 to 16
Dose level in the evaluation period
Time frame: Week 12 to 16
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Grenoble, France
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Pierre-Bénite, France
...and 41 more locations