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 14 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 5 hospitals in the UK. Bayer HealthCare AG is funding this research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
25mg Tablet
Matching placebo tablet
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Gosford, New South Wales, Australia
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Melbourne, Victoria, Australia
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Gabrovo, 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
Change in local laboratory hemoglobin level from baseline
Time frame: Baseline up to 12 weeks
Speed of change in hemoglobin level per unit time
Time frame: Up to 16 weeks
Duration of treatment exposure
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
Pharmacodynamics characterized by erythropoietin concentration
Time frame: Several time points up to 16 weeks
Pharmacodynamics characterized by reticulocyte count
Time frame: Several time points up to 16 weeks
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Stara Zagora, Bulgaria
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Veliko Tarnovo, Bulgaria
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Limoges Cedex1, France
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Villingen-Schwenningen, Baden-Wurttemberg, Germany
...and 46 more locations